Methods and Devices for Portable Sterilization and Containment of Medical Devices

ABSTRACT

An at-home sterilization and data acquisition and deposition device including a housing having an opening or series of openings for receiving up to six medical devices, a sterilization chamber formed within the housing that is lined with sterilizing radiation reflecting material, and several sources of sterilizing radiation disposed within the sterilization chamber for sufficient emission of radiation to achieve a significant log reduction of any pathogens present on the medical devices, and an RFID scanner and sensor suite configured into the housing that prevents sterilization of non-system components, radiation emission into the environment, and that can pair with a user&#39;s mobile device. An individual catheterization system includes an at-home sterilization and data acquisition device, a software-enabled analysis of data acquired through the system, a set of accessories to enable proper lubrication, cleaning, and radiation-based sterilization of medical devices, and a set of RFID-enabled medical devices designed to facilitate sterile emptying of the bladder by providing a tactile interface that prevents direct contact between the individual and the parts of the medical devices that enter the individual&#39;s body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/399,658, filed Apr. 30, 2019, which claims priority to U.S.Provisional Patent Application No. 62/664,744, filed Apr. 30, 2018,entitled Methods and Devices for Portable Sterilization and Containmentof Medical Devices, which is incorporated herein by reference in itsentirety and made a part hereof.

TECHNICAL FIELD

The present invention generally relates to sterilization radiationsystems, and, more particularly, to methods and systems for urinarycatheterization, urinary catheter sterilization, and combined dataacquisition and deposition.

BACKGROUND OF THE INVENTION

Intermittent urinary catheters and catheter systems are well known inthe art. While intermittent urinary catheters and catheter systemsaccording to the prior art provide a number of advantageous features,they nevertheless have certain limitations. The present invention seeksto overcome certain of these limitations and other drawbacks of theprior art, and to provide new features not heretofore available. A fulldiscussion of the features and advantages of the present invention isdeferred to the following detailed description, which proceeds withreference to the accompanying drawings.

SUMMARY

The present invention generally provides methods and devices for urinarycatheterization, urinary catheter sterilization, and combined dataacquisition and deposition.

According to one embodiment, a sterilizer for sterilizing one or moremedical devices may include a housing including one or more wallsdefining a sterilization chamber for containing electromagneticradiation and for the enclosing of the one or more medical devices, atleast one electromagnetic radiation source comprising a plurality ofelectromagnetic radiation emitters arranged in an at least one array,and an internal control circuit for controlling a sterilization cycle.The housing may have one or more openings for receiving the one or moremedical devices and a door that hinges open to allow individual accessto the one or more medical devices. The door may provide a seal betweenthe sterilization chamber and an external environment when closed. Theemitters may be positioned to emit electromagnetic radiation within thesterilization chamber. The internal control circuit may include an RFIDscanner for use with the one or more medical devices. The internalcontrol circuit may also include a plurality of sensors that validatethe sterilizer is completely closed during the sterilization cycle,prevent sterilization of non-system components, and prevent radiationemission into the external environment. The plurality of sensors mayinclude a radiation sensor located in a hardest to sterilize locationwithin the housing, wherein the sterilization cycle continues until theradiation sensor has received a radiation dose greater than a minimumradiation dose set within the internal control circuit. Thesterilization chamber may including a liner with sterilizing radiationreflecting material adapted to reflect and distribute the radiation.

According to another embodiment, a sterilizer for sterilizing one ormore medical devices may include a housing including one or more wallsdefining a sterilization chamber for containing electromagneticradiation and for enclosing the one or more medical devices, one or moreindividualized trays that correspond to the one or more medical devices,at least one electromagnetic UV-C radiation source comprising aplurality of mercury-based UV-C emitting bulbs arranged in an at leastone array and embedded within the one or more walls of the sterilizationchamber, and an internal control circuit for controlling a sterilizationcycle with sterilizer software. The housing may have one or moreopenings for receiving the one or more medical devices and a door thathinges open to allow individual access to the one or more medicaldevices. The door may provide a seal between the sterilization chamberand an external environment when closed. Each individualized tray mayindependently pivot out of the sterilizer for ease of loading by a user.The bulbs may be positioned to emit electromagnetic UV-C radiationwithin the sterilization chamber. The internal control circuit mayinclude an RFID scanner that validates an authenticity of the one ormore medical devices placed within the sterilizer and writes data to anRFID chip embedded in each of the one or more medical devices. Theinternal control circuit may further include a plurality of sensors thatvalidate the sterilizer is completely closed during the sterilizationcycle, prevent sterilization of non-system components, and preventradiation emission into the external environment. The plurality ofsensors may include a UV-C sensor located in a hardest to sterilizelocation within the housing, wherein the sterilization cycle continuesuntil the UV-C sensor has received a UV-C radiation dose greater than aminimum UV-C radiation dose set within the internal control circuit. Thesterilization chamber may include a liner with sterilizing radiationreflecting material adapted to reflect and distribute the UV-Cradiation.

According to another embodiment, a method for sterilizing one or moremedical devices using electromagnetic radiation may include: enclosingone or more medical devices in a sterilizer; scanning, by an RFIDscanner within the sterilizer, the one or more medical devices placedwithin the sterilizer to validate the authenticity of the one or moremedical devices; write, by the RFID scanner, data to an RFID chipembedded in each of the one or more medical devices; sealing thesterilization chamber with a door that hinges open to allow individualaccess to the one or more medical devices; starting a sterilizationcycle with an internal control circuit for controlling the sterilizationcycle with sterilizer software; and irradiating surfaces of the one ormore medical devices with electromagnetic radiation from at least oneelectromagnetic UV-C radiation source. The sterilizer may include ahousing with one or more walls defining a sterilization chamber forcontaining electromagnetic radiation. The sterilization chamber mayinclude a liner with sterilizing radiation reflecting material adaptedto reflect and distribute the radiation. The door may provide a sealbetween the sterilization chamber and an external environment whenclosed. The internal control circuit may include a plurality of sensorsthat validate the sterilizer is completely closed during thesterilization cycle, prevent sterilization of non-system components, andprevent radiation emission into the external environment. The pluralityof sensors may include a UV-C sensor located in a hardest to sterilizelocation within the housing, wherein the sterilization cycle continuesuntil the UV-C sensor has received a UV-C radiation dose greater than aminimum UV-C radiation dose set within the internal control circuit. Theelectromagnetic UV-C radiation source may comprise a plurality ofmercury-based UV-C emitting bulbs arranged in an at least one array andembedded within the one or more walls of the sterilization chamber. Thebulbs may be positioned to emit electromagnetic UV-C radiation withinthe sterilization chamber thereby destroying biological contaminants onthe surfaces of the one or more medical devices.

According to yet another embodiment, a sterilization system may includeone or more urinary intermittent catheters, one or more catheterinsertion aids that mate with the one or more catheters and providesupport and lubrication to the one or more catheters, and a sterilizerfor sterilizing the one or more catheters and the one or more catheterinsertion aids. The one or more urinary intermittent catheters may bemade from UVC-transparent and flexible material. The one or morecatheters may include a curved funnel and an RFID chip that containsauthentication information and usage information. The one or moreinsertion aids may include a flexible insertion tip that matches aFrench size of the catheter. The one or more insertion aids may furtherinclude an RFID chip that contains authentication information and usageinformation. The sterilizer may include a housing including one or morewalls defining a sterilization chamber for containing electromagneticradiation and for enclosing the one or more catheters and the one ormore insertion aids, one or more individualized trays that correspond tothe one or more catheters and the one or more insertion aids, at leastone electromagnetic UV-C radiation source comprising a plurality ofmercury-based UV-C radiation emitting bulbs arranged in an at least onearray and embedded within the one or more walls of the sterilizationchamber, and an internal control circuit for controlling a sterilizationcycle with sterilizer software. The housing may have one or moreopenings for receiving the one or more catheters and the one or moreinsertion aids and a door that hinges open to allow individual access tothe one or more catheters and the one or more insertion aids. The doormay provide a seal between the sterilization chamber and an externalenvironment when closed. Each individualized tray may independentlypivot out of the sterilizer for ease of loading by a user. The bulbs maybe positioned to emit electromagnetic UV-C radiation within thesterilization chamber. The internal control circuit may include an RFIDscanner that validates an authenticity of the one or more catheters andthe one or more insertion aids placed within the sterilizer and writesdata to the RFID chips in each of the one or more catheters and the oneor more insertion aids. The internal control circuit may further includea plurality of sensors that validate the sterilizer is completely closedduring the sterilization cycle, prevent sterilization of non-systemcomponents, and prevent radiation emission into the externalenvironment. The plurality of sensors may include a UV-C sensor locatedin a hardest to sterilize location within the housing, wherein thesterilization cycle continues until the UV-C sensor has received a UV-Cradiation dose greater than a minimum UV-C radiation dose set within theinternal control circuit. The sterilization chamber may further includea liner with sterilizing radiation reflecting material adapted toreflect and distribute the UV-C radiation.

Other features and advantages of the invention will be apparent from thefollowing specification taken in conjunction with the followingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

To understand the present invention, it will now be described by way ofexample, with reference to the accompanying drawings in which:

FIG. 1A is a perspective cross-sectional side view of an illustrativeembodiment of an apparatus according to one embodiment of the invention.

FIG. 1B is a front side view of the apparatus of FIG. 1A according to anembodiment of the invention.

FIG. 2 is a perspective side view of an illustrative embodiment of anapparatus according to another embodiment held by a left hand of anindividual and a medical catheter held in a right hand.

FIG. 3 is a perspective side schematic view of an embodiment of a lightsource sub-assembly according to another embodiment of the invention.

FIG. 4 is a cross sectional side view of an illustrative embodiment of amedical device, a contamination container enclosing the medical device,and an introducer tip.

FIG. 5 is an external perspective side view of an illustrativeembodiment of an apparatus held in an illustrative embodiment of aholster system attached to a wheelchair.

FIG. 6 is a logic block diagram describing the mechanics of theelectronic controls of an apparatus according to one embodiment of theinvention.

FIG. 7A is an external perspective front view of an illustrativeembodiment of a charging dock system charging an apparatus according toone embodiment of the invention.

FIG. 7B is an external perspective side view of the system of FIG. 7Aaccording to an embodiment of the invention.

FIG. 8 is a perspective side view of an apparatus according to onepreferred embodiment of the invention.

FIG. 9 is a perspective front view of an illustrative embodiment of theapparatus with the lid open.

FIG. 10 includes various views of an illustrative embodiment of theapparatus, featuring a front, left, right, top, bottom, and isometricview.

FIG. 11 is an isometric view of an illustrative embodiment of theapparatus with the door open and an individualized tray, speciallyadapted to receive a medical device, pivoted outwards.

FIG. 12 is an isometric exploded view of an illustrative embodiment ofthe apparatus.

FIG. 13 is a side view of an illustrative embodiment of an RFID-taggedmedical device specially adapted for use by males for the purposes ofurinary catheterization.

FIG. 14 is a side view of an illustrative embodiment of an RFID-taggedmedical device specially adapted for use by females for the purposes ofurinary catheterization.

FIG. 15 is a flowchart for a method for sterilizing one or more medicaldevices using electromagnetic radiation according to aspects of thisinvention.

The above-mentioned and other features of the inventions disclosedherein are described below with reference to the drawings of thepreferred embodiments. The illustrated embodiments are intended toillustrate, but not to limit the inventions.

DETAILED DESCRIPTION

While this invention is susceptible of embodiments in many differentforms, there is shown in the drawings and will herein be described indetail preferred embodiments of the invention with the understandingthat the present disclosure is to be considered as an exemplification ofthe principles of the invention and is not intended to limit the broadaspect of the invention to the embodiments illustrated.

In the following detailed description for purposes of explanation andnot limitation, exemplary embodiments disclosing specific details areset forth in order to provide a thorough understanding of the presentinvention. It will be apparent, however, to one having ordinary skill inthe art that the present invention may be practiced in other embodimentsthat depart from the specific details disclosed herein. In otherinstances, detailed description of well-known devices and methods may beomitted so as not to obscure the description of the present invention.

In medicine and therapeutic treatments, a catheter is a tube that can beinserted into a body cavity, duct, or vessel. Catheters thereby allowdrainage, injection of fluids, diagnostic agents, and/or medicine, oraccess by surgical instruments. In most uses, a catheter is a thin,flexible tube (i.e. a “soft” catheter) and, in some uses, a larger,solid tube (i.e. a “hard” catheter). Various catheter tip designs areknown including coudé tips, stepped tips, tapered tips, over-moldedtips, split tips, and so forth. Catheters may include variousaccessories such as molded components, over-molded sub-assemblies,connecting fittings such as hubs, extension tubes, and so forth.

During and after use, catheters can be colonized by micro-organisms ifthe catheters come in contact with the user's unsterilized skin,specifically on the perineum and the tip of the urethra. The colonizingmicro-organisms can multiply and form a biofilm layer within 24 hours ofcatheter use, during which they are metabolically active and viable.Catheters contaminated with said microorganisms are known to causenegative health outcomes such as UTIs when used without sterilization.It is known that while there are homemade means to sterilize catheterssuch as rinsing the used catheter followed by submerging in isopropylalcohol for a five-minute duration, inconsistent rinsing andinappropriate post-sterilization storage causes re-contamination ofcatheters by exposing them to potential colonization by micro-organismsand leads to negative health outcomes for the user.

The invention relates to enabling medical device users (e.g., catheterusers) concerned with sterilizing their products from bacteria and othermicroorganisms to use a portable germicidal device that utilizesradiation to sterilize the medical product(s), safely shields the userfrom radiation or other exposure during such sterilization, and providessterile storage of the catheter or other medical product until needed.Moreover, the devices, systems, and methods according to the inventionpreferably provide increased standardization for sterilizing cathetersor other products to reduce the risk of inadequate and/or inconsistentsterilization.

One aspect of the invention relates to systems and/or apparatusescapable of sterilizing medical products, preferably catheters, or otherproducts using radiation. The apparatus of the present invention can beefficiently configured and designed to provide sterilization of thesurfaces of a medical device by emitting radiation in a range sufficientand effective to destroy contaminants including pathogens andmicroorganisms. According to one preferred embodiment, radiationemitting diodes are placed in an array such that radiation is emittedinto the interior of the apparatus enclosing the medical device forsterilization. The array may be configured linearly, circularly, orrectangularly to form a matrix of diodes and may be located on, within,or behind the interior wall of the sterilization chamber. Preferably,the systems and/or apparatuses can repeatedly sterilize medical products(e.g., catheters) without damaging them.

One preferred embodiment relates to a device comprising an interiorchamber adapted to enclose a medical device and adapted to irradiate themedical device with radiation to sterilize the medical device.

Another embodiment relates to an apparatus for sterilizing a medicaldevice, the apparatus comprising: (a) one or more walls defining aninterior for containing radiation and for enclosing the medical device;(b) at least one radiation source comprising a plurality of radiationemitting diodes, wherein the diodes are positioned to emit radiationwithin the interior; (c) a power source capable of providing energy tothe diodes; and (d) one or more openings adapted to provide a sealbetween the interior and external environment when closed.

Another aspect of the invention relates to methods of sterilizing one ormore medical devices or other products using radiation. One embodimentof the invention relates to a method for sterilizing a medical deviceusing ultraviolet (UV) radiation comprising: (a) enclosing the medicaldevice in a chamber; (b) sealing the chamber; and (c) irradiatingsurfaces of the medical device with UV radiation thereby destroyingbiological contaminants on the surfaces of the medical device.

Another embodiment of the invention relates to a method for sterilizinga medical device using microwave radiation comprising: (a) enclosing themedical device in a chamber; (b) sealing the chamber; and (c)irradiating surfaces of the medical device with microwave radiationthereby destroying biological contaminants on the surfaces of themedical device.

Another embodiment of the invention relates to a method for sterilizinga medical 20 device using thermal radiation comprising: (a) enclosingthe medical device in a chamber; (b) sealing the chamber; and (c)irradiating surfaces of the medical device with thermal radiationthereby destroying biological contaminants on the surfaces of themedical device.

Another aspect of the invention relates to a system comprising at leastone apparatus or device as described herein and one or more additionalcomponents to facilitate the convenient sterilization of one or moremedical products using radiation.

The foregoing has outlined some of the aspects of the present invention.These aspects should be construed strictly as illustrative of some ofthe more prominent features and applications of the invention, ratherthan as limitations on the invention.

Many other beneficial results can be obtained by modifying theembodiments within the scope of the invention. Accordingly, for otherobjects and a full understanding of the invention, refer to the summaryof the invention, the detailed description describing the preferredembodiment in addition to the scope of the invention defined by theclaims and the accompanying drawings. The unique features characteristicof this invention and operation will be understood more easily with thedetailed description and drawings. It is to be understood that thedrawings are for illustration and description only and do not define thelimits of the invention.

It is known that in some settings and some circumstances, radiation ofvarious wavelengths can inactivate microorganisms such as bacteria,virus, fungi, protozoa, algae, and so forth using electromagnetic wavesof various wavelengths and bands, including ultraviolet light, thermalradiation, and microwave radiation. Ultraviolet light is typicallycharacterized in the following wavelength bands: ultraviolet-C (UVC)having a wavelength of 100 to 280 nm, ultraviolet-B (UVB) having awavelength 280 to 320 nm, and ultraviolet-A (UVA) having a wavelength of320 to 400 nm. Microwaves are characterized with a wavelength between 1mm to 1 m, where most conventional microwave ovens operate near a 12 cmwavelength (2450 MHz). Thermal radiation is a broadband type of emissionthat isn't typically characterized by its wavelength band and most oftenreferred to as heat. In all cases, these types of radiation are oftenused to sterilize surfaces and/or objects in hospital settings.

It is noted all forms are radiation are dangerous for humans withsubstantial exposure with outcomes dependent on the wavelengths emitted.Dependent on the wavelength, UV can be absorbed by DNA extremely wellcausing DNA to mutate, which is the primary mechanism used to inactivatemicroorganisms through UV. However, this mechanism also applies tohumans, where high human exposure to UV causes radiation sickness,resulting in symptoms such as eye irritation and reddening, skinirritation, nausea, fever, disorientation, hair loss, cancer, and, inextreme cases, death. Microwaves and thermal radiation can causemolecules such as water to vibrate and heat up creating hydrothermalpressure within a cell body, causing damage to the cell wall, breakageof genomic DNA, and thermal coagulation of cytoplasmic proteinsresulting in cell death and/or inactivation. Again, this phenomenonapplies to human cells as well and high exposure to microwave and/orthermal radiation can result in burn injuries and co-morbidities thatcan result in death. For these reasons, high doses of any radiation mustbe prevented from striking humans.

One or more of the inventions relate to improved apparatuses, systems,and methods for sterilizing medical or other products using radiationand similar energy.

One aspect of the invention relates to apparatuses having an interior orinner chamber adapted to sterilize a medical device, preferably aportable device adapted to be used by individuals, preferably at home orat their convenience.

Another embodiment relates to a device comprising an interior chamberadapted to enclose a medical device and adapted to irradiate the medicaldevice with radiation to sterilize the medical device.

Another embodiment relates to an apparatus for sterilizing a medicaldevice, the apparatus comprising: (a) one or more walls defining aninterior for containing radiation and for enclosing the medical device;(b) at least one radiation source comprising a plurality of radiationemitting diodes, wherein the diodes are positioned to emit radiationinto the interior; (c) a power source capable of providing energy to thediodes; and (d) one or more openings adapted to provide a seal betweenthe interior and 25 external environment when closed.

Referring now to the Figures, there is shown a variety of embodiments ofintermittent urinary catheters and catheter systems. Additionally, eachof these variations may have a variety of optional equipment,components, and features associated therewith.

FIG. 1A shows a cross sectional view of one embodiment of an apparatus100 according to the invention. As illustrated, the apparatus 100includes a sterilization chamber 101 having interior 106 and the medicaldevice 114 positioned within the interior 106.

The interior 106 preferably comprises a top wall 102, a bottom wall 103,opposing side walls 104 and opposing side walls 105 (FIG. 1B), whichdefine the interior 106 of the chamber 101. Alternatively, interior 106can be configured with curved inner wall (e.g., egg-shell shaped withcurved sides and top and bottom). The sterilization chamber 101 isprotected by housing 107. As depicted, a preferred embodiment of theinvention is a rectangular block with rounded edges where one end hasone or more openings and has one or more switches 131 on one of theexterior walls. Furthermore, there is a structural skeleton 108 that isused to insulate the interior chamber 101 from the housing 107, provideadditional rigidity, and enhance heat dissipation.

Preferred embodiments are portable. The height/length 127, thickness128, and width 129 are denoted in FIGS. 1A and 1B. Preferably, theoverall dimensions of the apparatus housing are: height 127 of 5″ to 18″(preferably 6″ to 16″), length 128 of 1.5″ to 6″ (preferably 1.5″ to5″), width 129 of 1″ to 6″ (preferably 1.5″ to 5″). Preferably, thedimensions for the interior are: Height of 4″ to 14″ (preferably 5″ to12″), length of 0.75″ 15 to 4″ (preferably 1″ to 3″), width of 0.75″ to4″ (preferably 1″ to 3″).

According to preferred embodiments of the present invention, one or morewalls of the interior of the chamber are radiation reflective as todistribute radiation throughout the interior of the chamber. Thespectral reflectance of this chamber should be no less than 80%reflective to the emitted radiation wavelengths. Preferably, theinterior wall comprises aluminum.

The apparatus comprises multiple openings that can open and close: oneto insert the medical device 114 into interior 106 and one can be openedto allow access to a cavity 118 in the housing used to store replaceablemedical or cleaning supplies, preferably sterile gloves, isopropylalcohol, or betadine. Preferably, the apparatus includes lid 138 thatpivots about a hinge 115 allowing the lid to open or close. A sealinggasket 112 provides a releasable hermetic seal allowing sterile storageof the medical device 114 within interior 106. Once sealed, a magneticlock 119 is used to lock the apparatus during operation and storage. Amedical device 114 is shown positioned within the chamber with anchoredsupport 113 on the side wall 104.

The closed interior 106 compartment can substantially eliminate strayenergy from escaping the interior 106 while eliminating fluid exchangewith environment. Any suitable UV reflective material may beincorporated in the composition of the interior 106 wall or surfaceduring manufacture or assembly. Polished aluminum could be utilized as asurface material because of its high reflectivity. The sealing gasket112 is made of UV stable material such as silicone.

Disposed within the apparatus 100 are individual ultraviolet lightemitted diodes (UVLEDs) 109 placed in an array such that radiation isemitted into the interior. Preferably, the diodes have a peak emissionwavelength range of 240 to 320 nm and more preferably 285 nm.Preferably, the diodes have a radiant flux range of 0.1 mW to 100 mW.The sterilization chamber 100 of the present invention can provide thenecessary decontamination and sterilization measures to effectivelyensure a 5-log reduction [99.999%] of any residual biologicalcontaminants on the exposed or hard-to-reach crevices of a medicaldevice. Preferably, multiple UVLEDs 109 are arranged on or along one ormore of the walls and there is sufficient space to the opposing wall toallow reflection of the irradiation allowing irradiation of multiplesurfaces of a target consistently. For example, preferably LEDs 109 arerecessed into the walls of the interior 106 and configured to emit UVinto the interior 106. A heat sink 116 is affixed to the UVLEDs toimprove heat dissipation during operation. In the depicted embodiment,the heat sinks are applied to the outer surface of walls comprisinginterior 106 and in direct contact with the non-emitting surface of theUVLEDs 109. In another embodiment, one heat sink may be applied to anarray of diodes. In another embodiment, one heat sink may be applied perwall of the sterilization chamber.

A power supply 110 provides energy to the UVLEDs 109 and preferablycomprises an internal supply of energy such as a rechargeable battery. Amicrocontroller 111 is used to control operation of apparatus electroniccomponents such as the UVLEDs 109. This microcontroller 111 receivesinformation from a switch 131 which enables to the user to open andclose the magnetic lock 119. The microcontroller also receivesinformation from a UV sensor 122, humidity sensor 123, temperaturesensor 124, light sensor 125, and pressure sensor 126. This informationis used to determine whether the apparatus is in operation and whetherthe apparatus is functioning out of expectation. For instance, visiblelight should not be detected within the chamber once the chamber issealed and locked. If the switch is activated and visible light isdetected by the light sensor, the microcontroller will not allow theUVLEDs to operate. Other events include but are not limited to rapidtemperature swings, rapidly decreasing humidity during operation,detected pressure lower than atmospheric pressure.

A serial code reader 137 is used wherein a user would scan a serial coderelated to the medical device prior to sterilization to track the numberof times the medical device was irradiated in the apparatus. A memorycard 121 is used to log this event data. A wireless transmitter 130 isused to transmit this data to an external source such as a cellphone ora laptop.

Current operation of the apparatus can be viewed through the indicatorLED 133. For example, when the unit is not in operation and not sealed,the LED would be off. When the unit is sealed but not in operation, theLED would shine blue. When the unit is sealed and in operation, the LEDwould pulse purple. When the unit is sealed and finished with operation,the LED would shine green.

Potting material 117 is used to encapsulate electronic components inorder to mitigate radiation exposure, improve heat dissipation, andresist shock and vibration. As depicted, the potting material 117 isapplied as insulation in the volume or space between the housing 107 andsterilization chamber 106, for example where electronic components arehoused. Additional insulating material may be used to fill the cavitiesbetween the exterior walls of the apparatus and the sterilizationchamber to further insulate the apparatus interior from the exteriorenvironment.

As depicted in FIGS. 1A and 1B, the apparatus 100 further comprises atextured grip 135 to provide an ergonomic handle, allowing saferhandling of the apparatus. The apparatus further comprises an exteriorbumper guard 134 around the housing at each end to protect the apparatusfrom falls and shocks.

As depicted in FIGS. 1A and 1B, a micro fluid pump 136 is used to pumpfluid into and out of the chamber. In this embodiment, the fluid pump136 is used to pump a mixture of water, hydrogen peroxide, and silverparticles to enhance sterilization. It is known that hydrogen peroxideand silver particles enhance DNA inactivation when using in conjunctionwith UV radiation. After sterilization, the micro fluid pump 136 willremove remaining fluid within the chamber. Micro fluid pump 136 caneither be included within a unit that is attached to the apparatus as inFIG. 1A or integrated within the apparatus (e.g., enclosed withinhousing 107, preferably adjacent interior 106) as in FIG. 1B. Forexample, the apparatus may have a port to connect to a fluid pump toprovide fluid to the interior chamber.

According to one embodiment of the present invention, the exterior ofthe apparatus housing further comprises one or more external supports,legs, tabs or grips on the exterior surface of the housing to allow theunit to stand upright and in a stable manner.

Another preferred embodiment relates to an apparatus for sterilizingsurfaces of medical devices from contamination by microorganisms, theapparatus comprising: one or more walls which define an interior chamberfor containing UV radiation such that the interior chamber can beproportionally sized to enclose target medical device requiringsterilization; a housing for the interior chamber with sufficient spaceto accommodate electronic circuitry and components; a source ofradiation comprising a plurality of LEDs such that the LEDs can bepositioned in relation to the interior chamber and/or the one or morewalls; a power supply providing energy to the LEDs such that the LEDsemit UV radiation into the interior chamber; and one or more seals suchas a gasket or O-bearing positioned to provide a hermetic seal for theinterior chamber, preventing fluid and microorganism exchange betweenthe interior chamber of the apparatus and the exterior environment, sothat the plurality of UV LEDs substantially irradiate all surface areasof the target medical device with UV radiation and the apparatus furtherprovides sterile storage of medical device while being sterilized andthereafter.

FIG. 2 shows an external view of an apparatus with a medical deviceaccording to one embodiment and a user hand for scale. As illustrated,the system 200 includes the sterilization apparatus 201, medical device206, and a user hand 202. The sterilization apparatus 201 is shown in auser hand 202 to demonstrate the scale of portability of thisembodiment, though it is again noted that this is for the purposes ofexplanation and not a limitation. As illustrated, a medical device 206may be removably positioned to and from the interior of thesterilization apparatus 201. External switches 203 control the openingand closing through electrical controls. A sealing gasket 204 is used tocreate a hermetic seal to maintain a sterile interior environmentbefore, during, and after irradiation. A textured grip 205 is positionedto allow for optimal grip for users with low hand dexterity and gripstrength. Slippage grips 208 are used to reduce slippage when theapparatus is placed on a smooth surface. Preferably, both the texturedgrip and slippage grips are to be made of a durable and malleablematerial such as a silicone. Instructions 207 are placed on the exteriorto guide the user to the correct procedure. In this preferredembodiment, the instructions are printed though alternatively, theinstructions may also be preferably embossed. Personal identification209 is printed on the outside to allow users to identify theirapparatus. Alternatively, the personal identification may also bepreferably embossed.

In preferred embodiments of the present invention, a holster or clip(not shown) may be included to allow user to carry or mount or clip theapparatus 100 on their person or an object such as a wheelchair, asshown in FIG. 3 (discussed below).

According to the invention, the apparatus can be designed to be portable(both small and light) and easy to use. Preferably, the medical deviceis adapted for use by an individual (e.g., in the individual's home)and/or for common everyday use environments such as outdoors, while atwork, or traveling. Preferably, the medical device is adapted forinsertion into a patient (e.g., a catheter). Preferably, the medicaldevice is adapted to be used by the patient. Preferably, the medicaldevice is CLIA waived. Preferably, the medical device is adapted forhome use. Preferably, the device does not require calibration or morethan five steps to complete (e.g., open, insert medical product, close,sterilize and remove sterilized product).

According to preferred embodiments, the medical device is made from amaterial (e.g., plastic or glass) that is translucent to the radiationused for sterilization. Preferably, the medical device comprises plasticor glass. More preferably, the medical device consists essentially ofplastic or glass. Preferably, the medical device comprises a tube, morepreferably a plastic tube. Preferably, the medical device is a tubehaving a length ranging between 4-18″, preferably a length rangingbetween 6″ to 16″. Preferably, the medical device is flexible (e.g.,capable of being bent for insertion into interior as shown in FIGS. 1Aand 1B). Preferably, the radiation comprises induced high energy UV-Bexposure. Preferably, the radiation comprises induced high energy UV-Cexposure. Preferably, the radiation comprises UV radiation in the rangebetween 100 nm to 390 nm. Preferably, the radiation comprises inducedhigh energy thermal exposure. Preferably, the radiation comprisesinduced thermal radiation in the range between 150 and 450 degreesFahrenheit. Preferably, the radiation comprises induced high energymicrowave exposure. Preferably, the radiation comprises inducedmicrowave radiation in the range between 1 millimeter and 1 meter.

According to preferred embodiments, the type of radiation and intensityis optimized for the type of medical or other product being sterilizedand the microorganisms targeted. According to one example, the use of UVradiation at 0.01-10 J/cm2 for a 5-log reduction of Salmonellatyphimurium. Another example would be use of −12 minutes of 1200 wattmicrowave, preferably 0.4 MJ. It is noted that delivered dose isdependent on view factor and heat transfer coefficient.

According to preferred embodiment, the apparatus is adapted for and/orthe method of sterilizations uses interior chamber temperatures rangingfrom 150 to 450 (preferably 250 to 350) for a period of time rangingfrom 0.5 to 15 mins (preferably 1.5 to 10 minutes) to achievesterilization. Preferably, the radiation, duration, and temperatureranges selected are optimized for inactivating pathogens such as, butnot limited to, Escherichia Coli, Enterococci, Enterobacter, Klebsiellapneumoniae, Pseudomonas Aeuruginosa, Proteus mirabilis, Staphylococcusaureus, and Candida Albicans. Preferably, the radiation from theradiation source inactivates microorganismal contaminants on thesurfaces of the medical device, more preferably inactivates 95% of themicroorganismal contaminants on the surfaces of the medical device, evenmore preferably at least 99%, even more preferably 99.99%, and mostpreferred 100% deactivated (e.g., no detectible active microorganismalcontaminants).

The apparatuses according to the invention include a mechanism forgenerating and/or transmitting radiation or other energy into theinterior of the apparatus to sterilize the medical device enclosedtherein.

According to one embodiment, the apparatus comprises diodes configuredto generate and/or emit radiation into the interior or sterilizationchamber of the apparatus. According to one preferred embodiment, thediodes generate and/or emit thermal radiation. According to anotherpreferred embodiment, the diodes generate and/or emit UV radiation.According to another preferred embodiment, the diodes generate and/oremit thermal radiation. According to another preferred embodiment, thediodes generate and/or emit microwave radiation. Preferably, theplurality of diodes is arranged in at least one array. Preferably, theplurality of diodes is embedded within the one or more walls of theinterior. Preferably, the plurality of diodes is distributed throughoutthe inner surface of the interior.

According to preferred embodiments, the radiation source comprises aball or hemispherical lens system for optimal launch of radiation intothe interior and/or to protect the diodes from any fluids in theinterior. Preferably, the radiation source comprises a UV transparentoptical window for separating the fluid in the interior containing themedical device from the diode.

A cross-sectional side view of the light source sub-assembly accordingto one preferred embodiment is illustrated in FIG. 3. As illustrated,the light source sub-assembly 300 includes a UVLED 301, UV transparentwindow 302, and hemispherical lens 303.

The light source assembly 300 is positioned through apertures within theinterior chamber 106 walls (e.g., recessed into the interior walls). TheUV transparent window 302 separates the interior chamber 106 from theUVLED 301 to optimize light source operational lifetime by reducingexposure to potential user error and/or mechanical shock. Thehemispherical lens 303 allows for a wider viewing angle resulting inoptimal launch of the UVLED 301 irradiation into the interior 106. Inthis preferred embodiment, an adhesive 304 is used to attach the UVLED301 to the UV transparent window 302 and the UV transparent window 302to the hemispherical lens 303. The adhesive is made of a UV transparentmaterial to allow the UV radiation to travel through the adhesive withminimal loss.

Modifications of the present invention may also include incorporatingany type of LED, particularly those being developed to accommodate otherranges of wavelengths for sterilization. As a cost-effective choice,LEDs continue to be developed to improve their energy efficiency.Developments of organic light emitting diodes (OLEDs) could also be apossibility for being included in the present invention. The luminousefficiency which has led to development of organic light emitting diodescould also influence super-bright UV OLEDs to be developed for thepresent application. However, other UV light sources can also be used.According to preferred embodiments, the diodes are removable and may bereplaced by an end user or a qualified technician.

According to preferred embodiments, the apparatus is comprised ofcomponents (e.g., interior chamber, housing, circuitry, pump, etc.) andpreferably, the components are modular and may be replaced by an enduser or a qualified technician. According to additional embodiments, theinterior or inner chamber of the apparatus is further adapted to improvethe radiation sterilization.

According to preferred embodiments, the one or more walls of theinterior comprises a reflective coating or material adapted to reflectand distribute the radiation. Preferably, the reflective coating ormaterial comprises optically diffuse materials for spectral reflectance.Preferably, a coating or material providing interior reflectance.Alternatively, the walls or entire interior can be made using materialproving reflectance (e.g., the interior chamber is made of aluminum).

The apparatus preferably includes at least one opening or aperture forinserting and removing the medical device(s). Preferably, the apparatusfurther comprises a joint adapted to close and open the one or moreopenings allowing a user to insert and remove the medical devices fromthe interior. Preferably a kinematic joint, such as a hinge is used.FIGS. 1A and 1B shows hinge 115 which allows lid 138 to open. FIG. 2depicts the rotation of the lid to open the apparatus. Alternatively,the interior is comprised of two or more mated components containing oneor more sealing components to prevent fluid and microorganism exchangefrom the exterior environment and the interior. Preferably, theapparatus further comprises a containment system for holding the medicaldevice after sterilization and/or for holding a new replacement medicalproduct.

According to one preferred embodiment, the apparatus comprises acontainer for holding the medical device to protect the medical devicefrom contact contamination after removal from the interior within theapparatus, wherein the container is proportionally sized to enclose themedical device and inside the interior. Preferably, the container is atube. Alternatively, the container is a bag or a box. Preferably, thecontainer is made of polyurethane, silicone, fluoropolymer or composite(preferably PTFE, FEP, PVDF). Preferably, the container has an openingfor the medical device, even more preferably an opening that can openand close.

According to preferred embodiments, the container is within theapparatus housing or otherwise integrated within the apparatus.Alternatively, the container is attachable to the apparatus (e.g., viaclips) or is a separate component to be used with the apparatus.

According to preferred embodiments, the apparatus includes a containeradapted to hold the medical device and is also adapted to be enclosedwithin the interior sterilization chamber. FIG. 4 shows containersub-assembly 400 comprising a medical device (which in this embodimentis a catheter) 401, a contamination container 402, and an introducer tip403. The catheter 401 is fed through the contamination container 402 tominimize contact contamination post-irradiation. An introducer tip 403is placed at the end of the in vivo portion 404 to allow guided handlingduring insertion of medical device. The ex vivo portion 405 is at theother opening of the container. This sub-assembly 400 is entirely placedinto the interior of the apparatus to be irradiated and thus sterilizedand the sub-assembly 400 can then be handled with reduced risk ofcontact contamination during insertion. An alternative embodiment ofcontamination container 402 allows the medical device to be insertedinto the container such that only the in vivo portion of the device isinserted into the sterilization chamber for irradiation. The container402 also allows the sterilized medical device to be removed from theapparatus and protected against contamination.

According to preferred embodiments, the apparatus further comprises astructural material or composite backing the interior to enhancestructural rigidity. According to preferred embodiments, the apparatusfurther comprises a structural material or composite backing theinterior to enhance thermal dissipation. According to preferredembodiments, the apparatus further comprises a structural material orcomposite backing the interior to enhance exclusion from and of exteriorenvironment. For example, the structural material can be in the form ofa housing for the interior and inner components of apparatus (e.g.,diodes and circuits). Alternatively, the structural component can be inthe form of a “spine” along the length of the apparatus.

According to preferred embodiments, the apparatus further comprises ahousing fitted around the interior walls. Preferably, the housing ismade of chemically or microbially resistant material. Preferably, thehousing is made of one or more materials selected from the groupconsisting of aluminum, polyurethane, and rubber. Preferably, thehousing has one or more openings, preferably aligned with an opening ofthe interior chamber. Preferably, the housing has one or more cavitiesfor holding sterilization reagents or fluids, medical devices, etc. Evenmore preferably, the cavities have one or more openings that can beopened and closed. Preferably, the one or more cavities are locatedbetween the housing and the interior and the one or more cavities isfilled with material to insulate the interior from the exteriorenvironment.

According to preferred embodiments, the interior comprises a supportstructure to fasten or secure the medical device to allow consistentplacement of the medical device within the interior. Preferably thesupport structure is made of radiation reflective and/or radiationstable materials, such as aluminum. Preferably, the interior or innerchamber is proportionally sized to enclose the medical device.

According to preferred embodiments, the opening or lid used to insertthe medical device comprises one quarter to one third of the overallheight of the apparatus as depicted in FIG. 9 (and also depicted in FIG.1 and FIG. 8) such that the user has greater accessibility to themedical device when the apparatus is open and will be able to remove themedical device more easily than a lid comprising only the top wall ofthe housing.

FIG. 9 shows the apparatus 900 further comprises a lid 901 that rotatesaround a kinematic hinge 902 to provide access to the medical device 907when the apparatus 900 is open. In this embodiment, the apparatus 900further comprises UVLEDs 903, external switch 904, exterior grip 905,external bumper guard 906, interior 908, slippage guards 909, andindicator LED 910.

According to preferred embodiments, the apparatus is modified such thatwhen the apparatus is opened, the bottom wall of the interior is pushedtowards the opening therefore pushing any medical devices housed withinthe interior towards the opening. The control mechanism in this case isa motor controlled linear actuator and alternate forms include but notlimited to spring loading, pneumatic controls, and magnetic rail (e.g.,the interior chamber lifts up so the catheter comes out; potentiallyspring loaded or motor controlled or pneumatic).

According to preferred embodiments, one or more button switches aretwo-state depressible such that the button is seated in a neutralposition when untoggled and seats in a depressed position when toggleduntil the intended operation is completed or interrupted. (e.g.,pressable buttons with locking states; depressed in one state; uprightin the other).

According to preferred embodiments, one or more openings to theapparatus will be modified such that the medical device can besimultaneously removed from the interior and a lubricant is applied tothe exterior surface of the medical device during removal. This isintended to allow users to lubricate the medical device without the needof additional handling (e.g., self-lubricating pull out method). Thelubricant may further comprise of or be mixed with a pharmaceuticalagent intended for reducing active pathogens post-sterilization (e.g.,the device includes the ability to disperse pharmaceuticals on catheteras it lubricates). Alternatively, the pharmaceutical agent may beintended to counteract inflammation.

According to preferred embodiments, one or more openings has aself-closing door such that the opening will remain closed unless anobject pushes with sufficient force to open the door and the door willclose the opening when there is no force applied to the door.Furthermore, the apparatus has a motor-controlled mechanism to feed themedical device through the opening with a self-closing door (e.g.,self-loading system).

According to preferred embodiments, the apparatus further comprises apump (preferably a fluid pump) to pressurize or depressurize theinterior.

According to preferred embodiments, the apparatus comprises an internalcontrol circuitry to operate and/or control and/or measure the operationof the device and/or open/close the opening. For example, a logic blockdiagram for the electronic controls according to one embodiment isillustrated in FIG. 6. The logic sequence 600 is initiated by pushingthe operation switch 601. This communicates with the microcontroller 602which runs the operation protocol. Expected operational status isdenoted by dashed arrows while error pathways are denoted by solidarrows. The microcontroller detects whether light or UV is detectedwithin the chamber via visible light sensor 603 and UV sensor 605. Ifeither is detected above a set threshold, an operation error 604 occurswhere the UVLEDs are powered off and a red indicator LED is flashed as avisual cue for the user. If neither is detected above a set threshold,the magnetic lock engages 606 followed by the UVLED irradiation powercycle 607 in which the UVLEDs are turned on for a set time, a purpleindicator LED pulses throughout operation, and a feedback loop is rununtil completion. Within the feedback loop, the microcontroller tracksthe temperature via the temperature sensor 608, UV dose via UV sensor609, state of the magnetic lock 610, and the internal pressure viapressure sensor 611. If temperature decreases beyond a threshold withina 3 second timeframe OR UV dose drops below a set threshold OR themagnetic lock is unlocked at any point OR the pressure maintains ordrops below atmospheric pressure within the first 5 seconds ofoperation, an operation error 604 will be triggered where all UVLEDs arepowered off and a red indicator LED is flashed as a visual cue for theuser. If the UV irradiation power cycle 607 is successfully completed,all LEDs will power off and a green indicator LED will power on untilthe operation switch is toggled again to release the magnetic lock.

Preferably, the internal control circuitry comprises a control switchfor operation of the radiation source. Preferably, the internal controlcircuitry is adapted for monitoring the status of the apparatus. Forexample, indicate whether the apparatus is in sterilization mode(emitting radiation within the interior creating a risk if opened)and/or monitor the operations, “health” (e.g., whether diodes requirereplacing), performance (type and intensity of radiation, duration),etc. of the apparatus. Preferably, the internal control circuitrycontrols opening and closing the one or more openings by a mechanical orelectronic switch. Preferably, the internal control circuitry controlslocking the one or more openings through a mechanical or electroniclocking mechanism. For example, when the user clicks an “open” button,the circuitry releases a lock allowing the “door” to open. Preferably,the internal control circuitry communicates with a toggle switch.Preferably, the internal control circuitry interfaces with amicrocontroller that changes the state of a magnetic switch based onuser input. Preferably, the internal control circuitry interfaces with amicrocontroller that changes the state of a gear drive based on userinput.

According to preferred embodiments, the apparatus further comprises oneor more UV sensors (e.g., to detect the diode emissions) and/or one ormore pressure sensors (e.g., to measure the pressure within theinterior) and/or one or more humidity sensors (e.g., to measure withinthe interior) and/or one or more temperature sensors (e.g., to measurewithin the interior).

According to preferred embodiments, the apparatus further comprises oneor more operational status indicators, such as colored LEDs or a LEDdisplay, to indicate the operational state of the apparatus.

According to preferred embodiments, the apparatus further comprises atransmitter and/or receiver for wireless communication protocols.

According to preferred embodiments, the apparatus further comprises apotting material encapsulating electronic components configured for UVprotection, enhanced thermal management, and resistance to shock andvibration. Preferably, the potting material may be applied to one ormore walls of the interior chamber to insulate the interior and exteriorsurfaces and enhance thermal dissipation (e.g., act as a heat sink).Preferably, applied to outer surface of walls or inner surface (e.g.,contacting or exposed to interior. According to preferred embodiments,the potting material is within the volume between the housing andinterior chamber to act as insulation. Preferably, at least one heatsink is affixed to or adjacent to the diodes. The heat sink is placed insuch a way to not interfere with the diode emission. In one embodiment,the heat sink is placed on the external surface of the interior affixedto the non-emitting side of the diode. Preferably, at least one heatsink layer in thermal contact with one or more LEDs. Alternatively, alayer for each LED or each array of LEDs or at least one heat sink perside of interior.

According to preferred embodiments, the apparatus further comprises oneor more EMI shielding components or layers to protect electroniccomponents. According to preferred embodiments, power supply comprisesat least one battery. Preferably, the battery is rechargeable.Preferably, the battery may be charged through a wall outlet. Accordingto preferred embodiments, the battery may be charged by inserting theapparatus into a charging dock. Preferably, the apparatus is adapted tobe inserted into the dock at an angle to ensure accessibility andvisibility of the interior to wheelchair users. For example, FIGS. 7Aand 7B show a system 700 including an apparatus 701 (including buttons704 and 703 and grip 705) inserted into charging dock 702 according 25to one embodiment of the invention. The charging dock 702 connects to anexternal power supply, such as, but not limited to, a wall outlet (notshown). According to alternative preferred embodiments, the power sourceis powered using an external power source (e.g., may be powered orcharged through wall outlet).

According to preferred embodiments, the apparatus, preferably thecircuitry, further comprises memory storage. Preferably, the apparatusfurther comprises a serial code reader allowing serial numbers to belogged onto the memory storage. Preferably, a serial code readerallowing serial numbers to be transmitted via wireless communicationprotocols.

According to preferred embodiments, the battery is charged wirelessly(e.g., wireless charging). According to preferred embodiments, thebattery is charged with a regenerative charging method suchtriboelectric generation or solar photovoltaic charging (e.g.,regenerative battery).

According to preferred embodiments, the wireless transmitter transmitsdiagnostics in a HIPAA-compliant manner to relevant and authorizedhealthcare practitioners such as a primary care physician, urologist,occupational therapist, or registered nurse. Alternatively, the wirelesstransmitter transmits diagnostics to a telemedicine service (e.g.,transmits diagnostics to urologist or telemedicine service). Accordingto preferred embodiments, the wireless transmitter is able to transmitdata to a central online repository to be viewed via a diagnosticsdashboard. According to preferred embodiments, the wireless transmitteris able to transmit data to other local devices via near-field such asbut not limited to RFID or wireless communication protocols such as butnot limited to Bluetooth (e.g., transmit data to a diagnosticsdashboard; communicates to other devices (Internet of Things—IoT)).

According to preferred embodiments, the apparatus further comprises oneor more sensors to detect active and inactive cell population on asampled point of the medical device before and after sterilization cycleis operated (e.g., cell detection method via camera or other sensor).

According to preferred embodiments, the apparatus further comprises anultrasonic transducer (i.e., piezoelectric) used to transmit oscillatoryultrasonic waves into the interior. Ultrasonic waves are known as aneffective tool to removing physical debris on solid surfaces and wouldbe helpful in removing potential biofilm debris from the medical devicebefore or during the sterilization cycle (e.g., ultrasonics).

Another embodiment of the invention relates to apparatus using radiationto sterilize but also including the use of reagents or fluids tooptimize or enhance the sterilization process.

According to preferred embodiments, the further comprises a fluidadapted to enhance sterilization of the medical device. Preferably, thefluid is water. Preferably, the fluid contains hydrogen peroxide and/orcontains silver particles.

Another embodiment of the invention further comprises a gel coated ontothe interior and exterior surface of the medical device to enhancesterilization (e.g., a gel that enhances UV sterilization properties andsterilization methods). Preferably, the gel may also serve dual purposesas a sterilization enhancer and as a lubricant.

According to preferred embodiments, the apparatus is designed to beportable and easy to use by patients and/or caregivers. Specifically,the size, weight and overall design allows easy use. Preferably, theapparatus further comprises tabs and/or grips on the exterior of theapparatus to reduce slippage. Preferably, the apparatus furthercomprises a textured grip for the apparatus, even more preferably anergonomic grip (e.g., configured to be gripped by a hand).

According to preferred embodiments, the apparatus is configured to becarried, stored and used. Preferably, the apparatus further comprises anexterior bumper guard to protect the apparatus from falls and shocks.

FIG. 8 shows a portable apparatus 800 according to one preferredembodiment having a total length 807, width 809, and thickness 808.Apparatus 800 includes 20 bumpers 803 at each end for drop protection.Indicator light 802 is depicted along one edge, with textured grip 805,slippage grip 806, and operational button 804 on opposite side.Apparatus 800 has an opening 801 (shown as closed in FIG. 8) controlledwith switch 804. The length of the opening cap 810 is smaller than thelength of the body 811. Preferably, the apparatus further comprises acarrying sleeve with one or more cavities for holding medical suppliesand/or cleaning supplies (preferably, disposable medical supplies).Preferably, the apparatus further comprises a holster adapted to allowthe apparatus to be carried by a person and/or without the use of theirhands by mounting onto an object such as a wheelchair or table.

An isometric view of a system according to one preferred embodiment isdepicted in FIG. 5. The holster system 500 comprises a sterilizationapparatus 501 and holster 502. The holster 502, a shown, has severalpockets that may be opened or closed that allow insertion of thesterilization apparatus to be carried without the use of hands. A clip503 affixed to the holster allows the holster to be clipped onto theframe of a wheelchair. According to further preferred embodiment, theholster would include buckles and straps instead of a clip (e.g., toattached to a user's belt). Preferably a container with medical orcleaning supplies 504 is also carried within one or more of the holsterpockets. Preferred embodiments may carry sterile gloves, water-basedlubrication, isopropyl alcohol, or betadine. A remote control (in thisembodiment, a user's smartphone) 505 is used to monitor and controloperation of the sterilization apparatus via wireless communication.

According to preferred embodiments, the apparatus is adapted to beoperated through a remote control. Preferably, the remote control is acellular device (e.g., a smartphone). Preferably, the remote control isa personal computer. Preferably, the apparatus includes personalidentification information such as but not limited to name, address,phone number, preferably labeled on the exterior of the apparatus.

According to preferred embodiments, text and/or visual instructionsand/or personal identification information are labeled on the exterioror interior of the apparatus. For example, an arrow or a number near astub to put the catheter port into (e.g., to position a catheterconsistently), not intending for much text, if any, on the interior. Anillustrative example is depicted as 209 in FIG. 2. Preferably, textand/or visual instructions are labeled on the exterior or interior ofthe carrying sleeve.

According to preferred embodiments, the apparatus further comprises aremovable introducer tip for catheters, as shown as tip 403 in FIG. 4.Preferably, the introducer tip is made of UV transparent material orcomposite. Preferably, the introducer tip is made of microwavetransparent material or composite such as polyethylene. Preferably, theintroducer tip is made of heat resistant material such as silicone.

The apparatus further includes an opening or aperture in at least onewall or an entire wall that is capable of opening to allow placement ofthe target medical device within the interior chamber. The chamber soconfigured allows for the removable placement of the target device(e.g., catheter) into and out of the interior chamber of the apparatus.In preferred embodiments, the medical device is a catheter with one partin 5 vivo (e.g., as shown as 404 in FIG. 4) and one part ex vivo (e.g.,as shown as 405 in FIG. 4).

According to one embodiment of the present invention, one or more of thelight sources may include a ball or hemispherical lens system foroptimal launch of UV light within the interior and/or a UV transparentoptical window for separating the chamber 10 interior from the LED(e.g., as shown in FIG. 3).

According to one embodiment of the present invention, a support affixedto one or more walls may be included, allowing the target medical deviceto be suspended or positioned or held in place consistently such thatthe light source and support(s) allow all surfaces of the target deviceto be exposed to substantial and uniform UV irradiation.

According to one embodiment of the present invention, the apparatuscontains a sealing device for the opening such as a gasket or anO-bearing to prevent leakage of environmental fluids from contaminatingthe medical device.

According to one embodiment of the present invention, the power supplymay be portable (e.g., a battery), may be internally housed, and,preferably, may be rechargeable. The power supply provides energy to theLEDs such that the LEDs emit UV radiation into the interior. Inpreferred embodiments, the apparatus is adapted to be connected to anexternal power source via power cord (e.g., from a wall outlet) ordocking station (e.g., a power cord).

According to one embodiment of the present invention, the apparatuscontains internal control circuitry such as an Arduino microcontroller.Preferably, the control circuitry is configured and used to controloperation of the radiation source. Preferably, the control circuitrycommunicates with a network of switches and locks to enable the user toopen and close the apparatus. Preferably the lock may be a mechanicalmechanism such as a gear drive or an electronic mechanism such as amagnetic lock.

Furthermore, according to preferred embodiments of the presentinvention, the apparatus contains a number of sensors to detectenvironmental conditions such as UV, pressure, humidity, andtemperature. These sensors are used to detect any abnormalities innormal operation and feedback to an automatic locking system when theradiation source is emitting. An illustrative operating protocol isdepicted in FIG. 6.

According to one embodiment of the present invention, the apparatusfurther comprises a textured grip to provide an ergonomic handle,allowing safer handling of the apparatus. According to one embodiment ofthe present invention, the apparatus housing further comprises one ormore legs or supports or tabs or grips on the exterior surface of thehousing to allow the unit to stand upright and in a stable manner.According to one embodiment of the present invention, the apparatusfurther comprises an exterior bumper guard around the housing to protectthe apparatus from falls and shocks.

According to one embodiment of the present invention, the apparatusfurther comprises one or more cavities with one or more openingsintended for holding disposable medical or cleaning supplies such assterile gloves, lubricant, and betadine. An example is illustrated inFIGS. 1A and 1B. According to one embodiment of the present invention,the apparatus is adapted to be placed in an external holster, intendedto be carried by a person or mounted onto an object such as awheelchair. An example is illustrated in FIG. 5.

According to one embodiment of the present invention, the apparatus isfurther adapted to have one or more components to be modular, allowmaintenance and replacement by users or qualified technician (e.g.,allow for maintenance and replacement of diodes or frame or any part ofapparatus).

According to one embodiment of the present invention, the apparatusfurther comprises text and/or visual instructions on one or more of theexterior surfaces of the housing or one or more of the interior surfacesof the interior chamber. The instructions are intended to allow users toeasily grasp the correct procedure with minimal training and experience.An example of instruction would be a bubbled number to indicate the stepnumber along with an arrow pointing to a switch. An example isillustrated in FIG. 2. For example, description in text and/or visualinstructions, arrows or bubbled number on interior.

Another aspect of the invention relates to methods of sterilizing one ormore medical devices or other products using radiation. Preferably,method of sterilizing and sealing a medical device or other product in aportable enclosure. The method preferably comprises sealing a medicaldevice within a sterilization chamber comprising a plurality ofradiation emitting diodes such that the diodes emit radiation into thechamber and the radiation is confined to the interior enclosure andirradiates the surfaces of the medical device, for a predeterminedperiod of time defining a sterilization cycle, deactivating pathogenicbiological contaminants that may be present on the medical device.

One embodiment of the invention relates to a method for sterilizing amedical device using ultraviolet radiation comprising: (a) enclosing themedical device in a chamber; (b) sealing the chamber; and (c)irradiating surfaces of the medical device with UV radiation therebydestroying biological contaminants on the surfaces of the medicaldevice. Another embodiment of the invention relates to a method forsterilizing a medical device using microwave radiation comprising: (a)enclosing the medical device in a chamber; (b) sealing the chamber; and(c) irradiating surfaces of the medical device with microwave radiationthereby destroying biological contaminants on the surfaces of themedical device. Another embodiment of the invention relates to a methodfor sterilizing a medical device using thermal radiation comprising: (a)enclosing the medical device in a chamber; (b) sealing the chamber; and(c) irradiating surfaces of the medical device with thermal radiationthereby destroying biological contaminants on the surfaces of themedical device.

According to preferred embodiments, the radiation is generated usingUV-C LEDs. Preferably, the LEDs are automatically switched off due to asensor event trigger. For example, the opening is opened or the powersupply is insufficient, etc. Preferably, the method further comprisescleaning the medical device prior to the step of irradiating.Preferably, further comprising chemically or otherwise cleaning themedical device within the chamber. More preferred, the cleaning entailsusing a fluid such as water or isopropyl alcohol to be applied to theinterior surface and then removing the fluid along with contaminants bywiping with a clean and sterile towel, towelette, abrasive brush, orequivalent. According to preferred embodiments, the method furthercomprises additional irradiation pulse cycling steps after theirradiating.

According to preferred embodiments, the method further comprisesremoving the medical device from the chamber, utilizing the medicaldevice in vivo and repeating the method of enclosing and irradiating,preferably without damaging the medical device. In this way, the medicaldevice may be used for repeated cycles without loss of intendedfunctional properties. Preferably, the medical device is a cathetercomprising an ex-vivo portion and an in vivo portion.

According to preferred embodiments, the method further comprises using afluid added to the chamber to enhance UV sterilization. Preferably, thefluid comprises one or more components selected from the groupconsisting of water, hydrogen peroxide, and silver particles.

According to preferred embodiments, the method further comprisesmaintenance cleaning of the sterilization chamber using a cleaningsolution (preferably isopropyl alcohol) after the sterilization.

According to preferred embodiments, the method further comprisesrecharging the apparatus using a charging dock, as depicted in FIGS. 7Aand 7B. According to preferred embodiments, the method further comprisesdownloading data from the apparatus to an external device. In preferredembodiments, an additional step to clean product exterior with an agentsuch as water or isopropyl alcohol is used. In further preferredembodiments, an additional step to clean interior of apparatussterilization chamber with an agent such as water or isopropyl is used.In other preferred embodiments, the radiation is able to inactivatemicroorganisms in a manner that does not damage the inserted medicaldevice.

According to preferred embodiments, the method further comprisescleaning apparatus exterior using a cleaning solution (preferablyisopropyl alcohol) after the sterilization. Preferably, the methodfurther includes cleansing the medical device in water or other solutionprior to the step of irradiating. Event indicators of environmentalbreach or contamination during the sterilization cycle may be used tostop irradiation to avoid accidental human UV exposure. Preferably, themethod is repeated to sterilize the same medical device (e.g. catheter)or other device(s), preferably multiple times.

According to preferred embodiments, the apparatus is configured to beused in a system with at least one medical device, preferably anintermittent catheter. Preferably, the medical device is used in commoneveryday use environments such as outdoors, or in a home, or at work, orwhile traveling. Preferably, the medical device is adapted for insertioninto a patient. Preferably, the medical device is adapted to be used bya patient. Preferably, the medical device is CLIA waived. Preferably,the medical device is adapted for home use. Preferably, the medicaldevice is a plastic, more preferably consists essentially of plastic.Preferably, the medical device takes the form of a tube, preferably aflexible tube. In one preferred embodiment, the medical device consistsessentially of a material or composite transparent to radiation emittedfrom apparatus radiation source. In preferred embodiments, the medicaldevice consists essentially of a flexible material, more preferably themedical device consists of a flexible material or is flexible.

Another embodiment relates to a method for sterilizing a medical deviceusing different types of radiation. Preferably, the types of radiationare UV radiation, microwave radiation, and thermal radiation.Preferably, the methods comprise enclosing a medical device in achamber, sealing the chamber, and irradiating surfaces of the medicaldevice with radiation thereby destroying active biological contaminantson the surface of the medical device.

In preferred embodiment, the radiation is generated via UVLEDs whereinpreferably the UVCLEDs will automatically switch off by a sensor eventtrigger as previously illustrated in flowchart shown in FIG. 6.

In preferred embodiments, the method further comprises cleaning theexterior device with a cleaning agent such as water or isopropylalcohol.

In preferred embodiments, the method further comprises cleaning theinterior of the apparatus with a cleaning agent or mixture of cleaningagents including but not limited to water, hydrogen peroxide, and/orsilver particles. Preferably, the sterilization is repeatable on amedical device and does not damage the medical device in such a way toalter its intended functionality.

In preferred embodiments, the method further comprises additional pulsedcycling radiation as it has been noted in academic literature thatrepeated sterilizations can provide a potentially more effectivesterilization method than fixed output.

In preferred embodiments, the method further comprises the use of afluid to enhance sterilization properties of the apparatus. Preferably,the fluid comprises a combination of water, hydrogen peroxide, and/orsilver particles as all three have been noted in literature to enhancesterilization.

In preferred embodiments, the method further comprises using a chargingdock to recharge the sterilization apparatus power supply.

In preferred embodiments, the method further comprises downloading datafrom the sterilization apparatus to an external device (e.g., athumbdrive, a smartphone, laptop or other computer system). Preferably,the operational history is stored on local memory in the sterilizationapparatus to be transmitted (via cable or wireless) to a computer orcellphone for a user or healthcare practitioner to monitor.

In preferred embodiments, the method further comprises coating theinterior and/or exterior surfaces of the medical device with a gel toenhance sterilization prior to sterilization (e.g., a gel that enhancesUV sterilization properties). Preferably, this method further comprisesremoving the gel (e.g., by cleaning).

Another aspect of the invention relates to a system comprising at leastone apparatus as described herein for sterilization of medical productsand one or more additional components or devices to facilitate theconvenient sterilization of one or more medical products usingradiation. Preferably, the system is adapted for use by a patient.Preferably, the system is CLIA waived. Preferably, the system is adaptedfor home use. Preferably, the medical device is a medical device for usein common everyday use environments such as outdoors or in a home.Preferably, the medical device is adapted for insertion into a patient.Preferably, the medical device is adapted to be used by the patientand/or is CLIA waived and/or is adapted for home use. Preferably, themedical device comprises plastic or glass, even more preferably consistsessentially of plastic or glass. Preferably, the medical devicecomprises a tube, preferably a plastic tube.

According to one preferred embodiment, the system comprises a container(e.g., bag, carrier, case) and the system (including components) can beenclosed in the container. Preferably, the container can be carrier by apatient. Preferably, the largest dimension of the container is less thantwo feet and weight less than 10 lbs.

According to another embodiment, the system further comprises a remotecontrol for remote operation and monitoring the apparatus operationalstatus such as determining whether the apparatus is on or off anddetermining whether the sterilization cycle was completed or not yetstarted. According to a preferred embodiment, the remote control is acellular device or a personal computer. Another embodiment of theinvention relates to a system comprising an apparatus and at least onemedical device.

According to one preferred embodiment, the system further comprises aremote control. Preferably, the remote control is a cellular deviceand/or a personal computer.

According to one preferred embodiment, the system further comprises aholster for the apparatus. Preferably, the holster has straps and/orbuckles and/or clips to allow mounting the apparatus to objects.Preferably, the holster has one or more openings that can be opened orclosed.

According to one preferred embodiment, the system further comprises acontainer for holding the medical device to protect the medical devicefrom contact contamination after removal from the interior within theapparatus, wherein the container is proportionally sized to enclose themedical device inside the interior. Preferably, the container is a tubeor is a bag or is a box. Preferably, the container is made ofpolyurethane, silicone, fluoropolymer (ex. PTFE, FEP, PVDF), and/orcomposite.

According to preferred embodiments, the container has an opening for themedical device. Preferably, the opening can open and close. According topreferred embodiments, the system comprises the apparatus and a carryingcase for the apparatus. According to preferred embodiments, the systemcomprises the apparatus and at least one container containing cleaningsolution.

According to preferred embodiments, the system comprises the apparatusand a remote control for operating the apparatus. According to preferredembodiments, the system comprises the apparatus and a set ofinstructions for operating the apparatus. According to preferredembodiments, the system comprises the apparatus and a charging cable forcharging the apparatus. According to preferred embodiments, the systemcomprises the apparatus and a charging dock for recharging theapparatus.

According to another embodiment, the system comprises at least oneapparatus, a medical device, and a holster for which the apparatus wasadapted. This system is intended to allow a user to carry the apparatuswithout use of their hands. One preferred embodiment of the holsterincludes strap and/or buckles to allow the user to mount onto a fixedobject such as a wheelchair or around the user's shoulders and torso.

One preferred embodiment of the holster includes one or more openingsthat may be opened or closed to allow insertion of the apparatus andadditional items the user may carry. Additionally, these holes mayfunction as a tether for a rope to cinch and close the holster, orcarabiner to hang or carry the holster.

According to another embodiment, the system further comprises acontainer to protect the medical device from contact contamination afterremoving the device from the interior of the apparatus. An additionalfunction of this container is to guide and improve consistent placementof said medical device. This container is proportionally sized to themedical device to enclose said device and fit within said apparatusinterior. According to an embodiment of the container, it may take theform of a tube, bag, or box. An example is depicted in FIG. 4. Accordingto another embodiment of the container, the container is made ofpolyurethane, silicone, fluoropolymer, or composite material. In apreferred embodiment, the container is transparent to the radiationemitted from apparatus radiation source or sources. In a preferredembodiment, the container has an opening that can open and close forinsertion of said medical device.

According to an embodiment of the claimed system, the system furthercomprises a fluid to be used to enhance UV sterilization, preferably, afluid in one or more containers. Preferably, the fluid comprises one ormore components selected from the group consisting of water, hydrogenperoxide, and silver particles. Preferably, the fluid is contained in aseparate container. Preferably, the fluid container is housed in one ofthe apparatus cavities (e.g., the apparatus includes a cavity to fillwith the fluid).

Another embodiment of the system according to the invention furthercomprises a gel used to coat the interior and exterior surface of themedical device to enhance sterilization.

According to preferred embodiments, the system further comprises acharging dock for recharging the apparatus. Preferably, the chargingdock is designed such that the apparatus is inserted at an angle, asdepicted in FIGS. 7A and 7B. For example, this allows users who areseated (such as wheelchair bound users) to more easily access the dockand inspect the interior when the apparatus is opened.

As exemplified, the apparatus may include any chamber having diodeswhich emit radiation to sterilize targeted surfaces of medical devices.The invention being thus described, it would be obvious that the samemay be varied in many ways by one of ordinary skill in the art havinghad the benefit of the present disclosure. Such variations are notregarded as a departure from the spirit and scope of the invention, andsuch modifications as would be obvious to one skilled in the art areintended to be included within the scope of the following claims andtheir legal equivalents.

According to alternative aspects of the invention, the methods andsystems described above can be configured or adapted to sterilize otherproducts (e.g., cooking devices, eating utensils, surgical instruments,medical implants, contact lenses, manufacturing equipment componentsused for biological/pharmaceutical manufacturing or food production).That is, the invention described above can be used to sterilize anycomponent having a surface requiring sterilization.

FIGS. 10-14 illustrate another embodiment of methods and systems forurinary catheterization, urinary catheter sterilization, and combineddata acquisition and deposition. Specifically, FIGS. 10-14 illustrate anat-home sterilization and data acquisition and deposition deviceincluding a housing having an opening or series of openings forreceiving up to six medical devices, a sterilization chamber formedwithin the housing that is lined with sterilizing radiation reflectingmaterial, and several sources of sterilizing radiation disposed withinthe sterilization chamber for sufficient emission of radiation toachieve a significant log reduction of any pathogens present on themedical devices, and an RFID scanner and sensor suite configured intothe housing that prevents sterilization of non-system components,radiation emission into the environment, and that can pair with a user'smobile device. An individual catheterization system includes an at-homesterilization and data acquisition device, a software-enabled analysisof data acquired through the system, a set of accessories to enableproper lubrication, cleaning, and radiation-based sterilization ofmedical devices, and a set of RFID-enabled medical devices designed tofacilitate sterile emptying of the bladder by providing a tactileinterface that prevents direct contact between the individual and theparts of the medical devices that enter the individual's body.

Intermittent urinary catheters are essential medical devices that aretypically used by individuals with neurogenic bladder and lower urinarytract symptoms to manually empty the bladder of urine if it isneurologically or physically obstructed. While the use of thesecatheters is oftentimes considered to be the healthiest short- orlong-term method for bladder management, especially when compared toalternatives like suprapubic or indwelling catheters, improper use ofthese catheters can result in contact contamination of the catheter, thesubsequent introduction of pathogens to the bladder, and an overallsubstantially higher urinary tract infection [UTI] risk for theindividual. Additionally, improper use of the catheter is extremelylikely given the overall lack of ergonomic consideration in the designof the catheter in the case of standard, low-cost catheters. Whileeasier-to-use catheters do exist, they do so at a price point that isoften 5-7× the price of standard, low-cost catheters. Insurance coverageof these easier-to-use catheters is limited, and reuse is prevalent tooffset the financial cost to the individual. Moreover, compliance withclean catheterization guidelines is generally low due to their onerousnature and requirement of a vast kit of parts that are difficult, if notimpossible, to transport.

A need exists for an easy-to-use and affordable catheterization systemthat mitigates the UTI risk associated with the use of today'scatheters.

Specifically, as illustrated in FIGS. 10-12, a low-footprint sterilizer1000 may sterilize up to six catheters 1100, 1200 and insertion aids1106, 1206 simultaneously using UVC-bulbs 1003. Each catheter 1100, 1200and insertion aid 1106, 1206 may be sandwiched by the UVC bulbs 1003 tofacilitate adequate log reduction/sterilization of the catheter 1100,1200 between uses. The catheters 1100, 1200 and insertion aids 1106,1206 may each fit into an individualized tray 1007 within the unit 1000.Alternatively, the catheters 1100, 1200 and insertion aids 1106, 1206may be placed into resealable UVC-transparent plastic bags to facilitatetheir sterile transport after removal from the sterilizer 1000 after thecompletion of a sterilization cycle. Specifically, an at-homesterilization and data acquisition and deposition device 1000 includinga housing 1020 having an opening or series of openings 1001 forreceiving up to six medical devices 1100, 1200, a sterilization chamber1021 formed within the housing 1020 that is lined with sterilizingradiation reflecting material 1002, and several sources of sterilizingradiation 1003 disposed within the sterilization chamber 1021 forsufficient emission of radiation to achieve a significant log reductionof any pathogens present on the medical devices 1100, 1200, and an RFIDscanner 1004 and sensor suite 1005 configured into the housing 1020 thatprevents sterilization of non-system components, radiation emission intothe environment, and that can pair with a user's mobile device.

In accordance with other aspects of the present invention, the openingof the device housing 1020 consists of a two-panel door 1006 that swingsclear of the opening to facilitate easy access to the sterilizationchamber 1021 housed within, which in turn features individualized trays1007 specially configured to hold individual medical devices 1100, 1200for sterilization. These trays 1007 can be individually rotated outwardsto expose their contents for removal, access, and deposit as seen inFIG. 11. In accordance with yet other aspects of the present invention,the door 1006 used to access the interior of the device 1000 comprisesone quarter to one half of the overall surface of the device 1000 suchthat the user has greater accessibility to the individual trays 1007when the device 1000 is open and will be able to remove or depositmedical devices 1100, 1200 more easily than a lid comprising only thefront wall of the device 1000. In accordance with yet other aspects ofthe present invention, the door 1006 used to access the interior of thedevice 1000 may feature an embedded sealing gasket 1008 along the outerperimeter of the door 1006 that forms a hermetic seal with the walls ofthe sterilization device 1000 when closed, such that it is non-permeableby gas or liquid. In accordance with yet other aspects of the presentinvention, the closing of the door 1006 may initiate the beginning of asterilization cycle provided that other requirements for the initiationof a sterilization cycle are met.

In accordance with other aspects of the present invention, thesterilization chamber 1021 formed within the housing 1020 may be linedwith a sterilizing radiation reflecting material 1002 such as mirroredaluminum or PTFE to provide high reflection of any sterilizationradiation that is not absorbed or otherwise attenuated by the medicaldevices housed within the device 1000.

In accordance with other aspects of the present invention, the source ofthe sterilization radiation 1003 for the at-home sterilization and dataacquisition and deposition device 1000 consists of several low voltageUV emitters that produce one primary ultraviolet wavelength [253.7 nm,275 nm, 280 nm, or 285 nm] for the purposes of disinfection andsterilization. In a preferred embodiment of the present invention, theUV emitters 1003 are further defined as UV mercury-based lamps. Inaccordance with other aspects of the invention, these lamps are housedin individual quartz envelopes with a Teflon-based coating to provideshatter-resistant properties to the lamp housing 1020. In anotherpreferred embodiment of the present invention, the UV emitters 1003 arefurther defined as UV light emitting diodes as described above andillustrated in at least FIG. 1.

In accordance with other aspects of the present invention, the at-homesterilization and data acquisition and deposition device 1000 includesone or more RFID modules 1004 that verify the authenticity of allmedical devices 1100, 1200 placed within the device 1000 forsterilization through the scanning of RFID chips 1101, 1201 embedded inall of the aforementioned medical devices 1100, 1200 and writesinformation to the individual chips 1101, 1201 in accordance with thenumber of times that the at-home sterilization and data acquisition anddeposition device 1000 has been used to sterilize the medical devices1100, 1200. The RFID module 1004 may electronically interface with themicrocontroller and/or logic board that controls the emission ofsterilization radiation into the interior chamber 1021 of the device1000 for sterilization to prevent the emission of sterilizationradiation if an individual has placed a RFID-embedded medical device1100, 1200 that has been sterilized more than a pre-specified number oftimes. The RFID module 1004 may also electronically interface with asuite of sensors 1005 through a microcontroller and/or logic board toascertain whether or not a medical device 1100, 1200 lacking an RFID1101, 1201 has been inserted into the at-home sterilization and dataacquisition and deposition device 1000, and the microcontroller mayprevent the emission of radiation sterilization until the medical device1000 lacking an RFID has been removed from the at-home sterilization anddata acquisition and deposition device 1000.

In accordance with other aspects of the present invention, the at-homesterilization and data acquisition and deposition device 1000 mayinclude a safety interlock mechanism. The safety interlock mechanism mayconsist of a Hall Effect sensor and a rare earth magnet, and wherein theHall Effect sensor senses the magnetic field of the magnet when theaccess door 1006 is closed and sends a signal to the user interfaceindicating a ready state for the excitation of the radiation source1006. The sterilizer circuit and microcontroller logic may utilize asensor suite that includes but is not limited to hall effect,temperature, and pressure sensors to validate that the sterilizer iscompletely closed for the duration of the sterilization cycle, toprevent UVC radiation from escaping the sterilization unit. Inaccordance with yet other aspects of the present invention, the at-homesterilization and data acquisition and deposition device 1000 mayinclude an electronic safety mechanism. The electronic safety mechanismmay consist of a suite of sensors 1005 that detect ambient temperature,light, and pressure within the sterilization chamber 1021, and transmitsa signal to interrupt any on-going sterilization cycle upon detection ofa dramatic change in readings throughout the course of the cycle. Inaccordance with yet other aspects of the present invention, the at-homesterilization and data acquisition and deposition device 1000 mayinclude a feedback loop that consists of a radiation sensor or suite ofsensors placed in a hard-to-irradiate location within the sterilizationchamber 1021, wherein the sterilization cycle continues so long as thesensor or suite of sensors has not registered sufficient radiation tokill pathogens that cause UTIs. In accordance with yet other aspects ofthe present invention, the at-home sterilization and data acquisitionand deposition device 1000 may include a feedback loop that incorporatesone or more sensors to detect active and inactive cell population on asampled point of the medical device 1100, 1200 before and aftersterilization cycle is operated (e.g., cell detection method via cameraor other sensor).

In accordance with other aspects of the present invention, the at-homesterilization and data acquisition and deposition device 1000 may use anultrasonic transducer (i.e., piezoelectric) used to transmit oscillatoryultrasonic waves into the interior of the sterilization chamber 1021.Ultrasonic waves are known as an effective tool to removing physicaldebris on solid surfaces and would be helpful in removing potentialbiofilm debris from the medical device 1100, 1200 before or during thesterilization cycle (e.g., ultrasonics).

In accordance with other aspects of the present invention, a micro fluidpump is used to pump fluid into and out of the at-home sterilization anddata acquisition and deposition device 1000. In this embodiment, thefluid pump is used to pump a mixture of water, hydrogen peroxide, andsilver particles to enhance sterilization. It is known that hydrogenperoxide and silver particles enhance DNA inactivation when using inconjunction with UV radiation. After sterilization, the micro fluid pumpwill remove remaining fluid within the sterilization chamber 1021. Themicro fluid pump can either be included within a unit that is attachedto the apparatus or integrated within the sterilizer device 1000. Forexample, the sterilizer device 1000 may have a port to connect to afluid pump to provide fluid to the interior chamber 1021.

In accordance with other aspects of the present invention, the at-homesterilization and data acquisition and deposition device 1000 furthercomprises one or more EMI shielding components or layers to protectelectronic components. According to preferred embodiments, the powersupply comprises at least one adapter 1009 configured to interface withand receive power from a standard wall outlet.

In accordance with other aspects of the present invention, the at-homesterilization and data acquisition and deposition device 1000 may pairwith an individual's mobile phone or personal computer or other suchdevice to deliver usage statistics, detailed troubleshooting steps,status updates, as well as other data. This pairing may be furtherdefined as enabling an individual to scan the RFID-embedded medicaldevices 1100, 1200 to verify their authenticity as well as observe theremaining number of sterilizations possible for the scanned devices1100, 1200. This pairing may be further defined as enabling anindividual to remotely control the at-home sterilization device 1000through their mobile phone or personal computer or other such device.

In accordance with other aspects of the present invention, the at-homesterilization and data acquisition and deposition device 1000 may beconfigured to have a screen 1010 on the device 1000 in order tocommunicate to an individual using the device 1000 the current status ofa sterilization cycle, or otherwise indicate the remaining longevity ofthe RFID-embedded medical devices 1100, 1200 that are being used inconjunction with and are being sterilized by the at-home sterilizationdevice 1000. The remaining longevity of the RFID-embedded medicaldevices 1100, 1200 may additionally be communicated to an individual viaRGB LEDs 1011 corresponding to each individual medical device 1100, 1200located on the front face of the at-home sterilization device 1000.

In accordance with other aspects of the present invention, the at-homesterilization and data acquisition and deposition device 1000 mayinitiate a sterilization cycle when an individual presses a start button1012 located on the front face of the at-home sterilization device 1000,and may prematurely end a sterilization when an individual presses astop button 1013 located on the front face of the device 1000.

In accordance with other aspects of the present invention, the at-homesterilization and data acquisition and deposition device 1000 may beconfigured to vent heat generated from the electrical components andradiation emission sources held within through a series of vents 1014located on the top of the device 1000.

In accordance with other aspects of the present invention, the at-homesterilization and data acquisition and deposition device 1000 may beconfigured to be battery-powered and portable. This device 1000 may pairwith one or many at-home sterilization and data acquisition devices toaccurately track medical device 1100, 1200 usage and frequency.

In accordance with other aspects of the present invention, an individualcatheterization system may include an at-home sterilization and dataacquisition and deposition device 1000 with an RFID scanner 1004configured into the housing 1020 of said device 1000, a software-enabledanalysis of data acquired through the system, a set of accessories toenable to proper lubrication, cleaning, and radiation-basedsterilization of medical devices, and a set of RFID-enabled medicaldevices 1100, 1200 designed to facilitate sterile emptying of thebladder by providing a tactile interface 1102, 1202 that prevents directcontact between the individual and the parts of the medical devices thatenter the individual's body as illustrated in FIGS. 13 and 14.

In accordance with other aspects of the present invention, the set ofaccessories to enable proper lubrication, cleaning, and radiation-basedsterilization of medical devices 1100, 1200 may include a lubricantbottle that is specially adapted to mate with a port 1103, 1203 locatedon, and deposit lubricant without leaking into, a lubricant reservoir1104, 1204 that subsequently applies lubricant to the exterior surfaceof the portions of the RFID-enabled medical devices 1100, 1200 thatenter the body. The lubricant dispensed by the lubricant bottle may befurther comprised of or be mixed with a pharmaceutical agent intendedfor reducing active pathogens post-sterilization (e.g., the deviceincludes the ability to disperse pharmaceuticals on catheter as itlubricates). Alternatively, the pharmaceutical agent may be intended tocounteract inflammation.

In accordance with other aspects of the present invention, the set ofaccessories to enable proper lubrication, cleaning, and radiation-basedsterilization of medical devices 1100, 1200 may include a elongatesilicone brush capable of dispersing chemical sterilizing agents inpowder, gel, or liquid form while also abrading pathogenic residueand/or biofilms from the interior surface of an elongate, tubularmedical device without causing damage to the interior surface of theelongate, tubular medical device.

In accordance with other aspects of the present invention, theRFID-enabled medical devices 1100, 1200 may be comprised of a set ofmating stiff and flexible components that detach for easy cleaning,which are further comprised of components that intended for use outsideof and inside of the body. These devices 1100, 1200 may include curvedfunnels 1105, 1205 at their distal end to facilitate the flow of liquidthroughout the devices 1100, 1200 while minimizing the splashing ofliquid. These devices 1100, 1200 may include stiff insertion aids 1106,1206 that are adapted to male and female anatomy to provide structureand support during the insertion of flexible urinary catheters, andwhich further provide a means of sterile lubrication, alignment, andinsertion of urinary catheters into the urethral tract. These devices1100, 1200 may include components that allow the devices to self-sealthrough the implementation of a quarter-turn luer lock or some othersubstantially sealing and mating mechanisms 1107, 1207 in the distalfunnel 1105, 1205 and proximal insertion aid 1106, 1206 ends of thesedevices 1100, 1200, in order to allow individuals to carry these devices1100, 1200 in transit without fear of leakage from the devices 1100,1200 once they have been used.

The insertion aids 1106, 1206 may be further comprised of flexible bags1108, 1208 that mate to both the catheter and the stiff components ofthe insertion aids via stiff collars 1109, 1209, therein providing aprotective yet tactile barrier that allow individuals to directlymanipulate the flexible catheters without contaminating them withpathogens. These devices 1100, 1200 may be made from materials with ahigh degree of sterilization radiation transparency such aspolypropylene film. These devices 1100, 1200 may be engineered withadditional reinforcing material in structurally vulnerable areas such aseyelets and joins in order to maximize their lifespan over apre-specified period of use. These devices 1100, 1200 may be soengineered in order to be successfully reused and sterilized in theat-home sterilization device 1000 fifty to one hundred times each. Thesedevices 1100, 1200 may be designed to maximize usability by individualswith limited dexterity through the incorporation of oversize tabs andother accessible features through their design.

In accordance with yet other aspects of the present invention, theindividual catheterization system may include an electronic medicalrecord or medical device distribution data interface that utilizes datagathered from the RFID scanner 1004 within the sterilization and dataacquisition and deposition device 1000 in a HIPAA compliant manner andsecurely transmits it to various stakeholders in the healthcareecosystem, including, but not limited to, urologists, occupationaltherapists, physical therapists, and medical device distributors. Thisdata interface may further be comprised of an anonymization andaggregation of the data gathered from all deployed sterilization anddata acquisition and deposition devices in order to analyze trends andcorrelations of catheterization practices and urinary tract infectionincidence, and may further communicate to the user of such devices bestpractices for catheterization in order to avoid infections.

Specifically, the medical device 1100, 1200 may include or be acatheter. According to aspects of this invention, the catheter 1100,1200 may be a urinary intermittent catheter, primarily fabricated from aUVC-transparent and flexible material with a stiff funnel 1105, 1205fabricated from cyclic olefin copolymer or FEP, and intended to beinserted into the human body for 3-5 minutes at a time to facilitate thedrainage of urine from the bladder into a receptacle. For males, thecatheter 1100, 1200 may likely be between 11.5 and 12 inches long (notincluding the funnel, which is itself 1 inch long); for females, thecatheter 1100, 1200 may likely be between 3 and 5 inches long (notincluding the funnel).

The catheter 1100, 1200 is tagged with an RFID chip 1101, 1201 that isscanned upon placement into the sterilizer 1000. The chip 1101, 1201 maycontain authentication information [e.g. serial number] as well as usageinformation [how many times that specific catheter 1100, 1200 has beensterilized]. This information could potentially grow to include time anddate of the last sterilization. This RFID tag might actually go on theinsertion aid 1106, 1206 instead of on the catheter 1100, 1200 directly.The electronics suite of the catheter 1100, 1200 may grow over time togive the catheter 1100, 1200 the capability to perform real-timeanalysis of the bioburden present within the urine. Each of theelectronic sensors used to perform this analysis would potentially storetheir readings in a separate RFID chip 1101, 1201 [e.g. an RFID array]or a single high-capacity RFID chip. The RFID tag present on thecatheter 1100, 1200 may also be scannable by mobile app and mobile phoneRFID reader to validate the number of uses left in the catheter 1100,1200 or insertion aid 1106, 1206 and generally access the dataremotely/in the absence of the sterilizer 1000.

The catheter 1100, 1200 may include many features related toreusability. For example, the catheter may include reinforced eyelets,such that the catheter 1100, 1200 may be reinforced with additionalmaterial around the drainage eyelets in order to withstand materialfatigue over time. In another example, the catheter 1100, 1200 mayinclude a reinforced mating area with the funnel 1105, 1205. Thecatheter 1100, 1200 may be reinforced with additional material aroundwhere it mates with a hard funnel 1105, 1205 to facilitate drainage ofurine away from the body, in order to withstand material fatigue overtime. The catheter 1100, 1200 may also be UVC transparent, such that allparts of the catheter 1100, 1200 may be made with UVC transparentmaterials that allow germicidal wavelengths of UV light tosimultaneously sterilize the interior and exterior surfaces of thecatheter 1100, 1200. The catheter 1100, 1200 may have a usage lifetimeof as much as 100 uses each.

The funnel 1105, 1205 of the catheter 1100, 1200 may also includevarious features. For example, the catheter 1100, 1200 may include acurved funnel 1105, 1205 that reduces material strain on the catheter1100, 1200 when stored in conjunction with the insertion aid 1106, 1206and reduces the flow rate of urine exiting the funnel 1105, 1205 end ofthe catheter 1100, 1200 by virtue of increasing surface area contactbetween the funnel 1105, 1205 walls and the urine. Additionally, thedistal end of the catheter funnel 1105, 1205 may include a quarter turnfemale luer lock component that mates with the proximal end of insertionaid 1106, 1206. This provides a substantially water-tight, air-tightseal. Additionally, this component can interface with a number ofcatheter product accessories such as a portable urine drainage bag or anadaptor that facilitates connection to a standard water bottle. The sealis substantially air- and water-tight, enabling a hermetic seal thatallows for sterile transport of the insertion aid 1106, 1206 and thecatheter 1100, 1200 once fully assembled.

Additionally, the proximal end of the catheter funnel 1105, 1205 mayinclude a female mating interface that either accepts a snap fit orthreaded male insert from the insertion aid 1106, 1206. This enables theinsertion aid 1106, 1206 and the catheter 1100, 1200 to be disassembledfor rinsing and cleaning. The seal is substantially air- andwater-tight, enabling a hermetic seal that allows for sterile transportof the insertion aid 1106, 1206 and the catheter 1100, 1200 once fullyassembled.

In another embodiment, the catheter 1100, 1200 may be include increasedusability by people with limited dexterity. These catheter 1100, 1200may include easy-to-grip plastic tabs and/or loops around each distinctcomponent of the catheter 1100, 1200 such that a single finger can beused to disassemble or assemble the catheter 1100, 1200 and insertionaid 1106, 1206. Additionally, the catheter 1100, 1200 may be made out ofbiodegradable/compostable plastics.

The medical device and catheter 1100, 1200 may include an insertion aid1106, 1206 as illustrated in FIGS. 13 and 14. The insertion aid 1106,1206 may include a stiff apparatus that mates with a flexible, thinplastic bag with threaded or snap fit collars. The stiff apparatusprovides support and lubrication to the catheter 1100, 1200 as it isbeing inserted into the body, while the flexible, thin plastic bag actsas a prophylactic barrier between the catheter 1100, 1200 and the humanbody, to reduce contact contamination risk at the moment of insertioninto the body.

The insertion aid 1106, 1206 may include an insertion tip. The proximalend of the insertion aid 1106, 1206 may include a flexible insertion tipwhose inner diameter matches the French size of the catheter 1100, 1200,with a thickness between 5 and 10 mils [thousandths of an inch]. The tipacts as a prophylactic barrier between the catheter 1100, 1200 and themeatus of the urethral opening. The insertion aid 1106, 1206 may alsoinclude an usability handle. For example, the male version of theinsertion aid 1106, 1206 features a usability handle that can be used tosupport the insertion aid 1106, 1206 against the shaft of the penisthroughout insertion. The usability handle may be designed so that onehand is sufficient to stabilize the insertion aid 1106, 1206 andcatheter 1100, 1200 while the other hand is used to insert the catheter1100, 1200 into the body.

The insertion aid 1106, 1206 may include an usability flange. The femaleversion of the insertion aid 1106, 1206 may include a flange at the baseof the insertion tip that female users can apply pressure to with theirfingers to hold the insertion aid 1106, 1206 securely against theurethral opening. The flange has been designed to be compatible with theanatomical geometry of the vagina, and can be used to securely hold theinsertion aid 1106, 1206 against the urethral opening whilesimultaneously spreading the labia apart for easier insertion of thecatheter 1100, 1200.

The insertion aid 1106, 1206 may include a lubrication reservoir thatcan hold a predetermined amount of lubricant without leakage. Forexample, as the catheter 1100, 1200 is inserted into the body andtravels through the reservoir and the insertion tip, the catheter 1100,1200 is coated with a thin layer of lubricant to facilitate insertion.The lubrication reservoir may be filled through a luer lock matingsystem, wherein the lubrication reservoir has a sealed female port thatmates with a male applicator tip that screws onto a refillablelubrication bottle.

The insertion aid 1106, 1206 may also include a stiff insertion aidproximal interface that is located at the proximal end of the stiffinsertion aid component and features a quarter turn male luer lockcomponent that mates with the proximal end of catheter 1100, 1200. Theseal is substantially air- and water-tight, enabling a hermetic sealthat allows for sterile transport of the insertion aid 1106, 1206 andcatheter 1100, 1200 once fully assembled. Additionally, the insertionaid 1106, 1206 may include a stiff insertion aid distal interface thatis located at the distal end of the stiff insertion aid component andfeatures a female mating interface that either accepts a snap fit orthreaded male insert from the insertion aid bag. This enables theinsertion aid 1106, 1206 and catheter 1100, 1200 to be disassembled forrinsing and cleaning. The seal is substantially air- and water-tight,enabling a hermetic seal that allows for sterile transport of theinsertion aid 1106, 1206 and catheter 1100, 1200 once fully assembled.

The insertion aid 1106, 1206 may also include a collared bag. A flexiblecomponent of the insertion aid 1106, 1206 may be comprised of a flexibleplastic bag that is bookended by collars that are either threaded orhave a snap fit feature on them to facilitate mating with and subsequentdisassembly from the insertion aid 1106, 1206 and catheter 1100, 1200.

Additionally, the insertion aid 1106, 1206 may include increasedusability by people with limited dexterity. For example, this increasedusability may include easy-to-grip plastic tabs and/or loops around eachdistinct component of the insertion aid such that a single finger can beused to disassemble or assemble the catheter 1100, 1200 and insertionaid 1106, 1206.

The insertion aid 1106, 1206 may be RFID tagged with an RFID chip 1101,1201 that is scanned upon placement into the sterilizer 1000. The chip1101, 1201 may contain authentication information [e.g. serial number]as well as usage information [how many times that specific catheter hasbeen sterilized]. This information could potentially grow to includetime and date of the last sterilization. This RFID tag might actually goon the insertion aid 1106, 1206 instead of on the catheter 1100, 1200directly. The electronics suite of the insertion aid 1106, 1206 mayinclude the insertion aid 1106, 1206 with the capability to performreal-time analysis of the bioburden present within the urine. Each ofthe electronic sensors used to perform this analysis would potentiallystore their readings in a separate RFID chip [e.g. an RFID array] or asingle high-capacity RFID chip.

The RFID tag present on the insertion aid 1106, 1206 may also bescannable by mobile app and mobile phone RFID reader to validate thenumber of uses left in the catheter 1100, 1200 or the insertion aid1106, 1206 and generally access the data remotely/in the absence of thesterilizer 1000.

All parts of the insertion aid 1106, 1206 may be made with UVCtransparent materials that allow germicidal wavelengths of UV light tosimultaneously sterilize the interior and exterior surfaces of theinsertion aid. The insertion aid 1106, 1206 may have a usage lifetime of100 uses each.

The sterilizer 1000 may include a sterilizer interface. The sterilizerinterface may provide a color-coded display for remaining uses. Thesterilizer 1000 may inform the user how many uses is left in eachcatheter 1100, 1200 based on their relative position within thesterilizer 1000. For example, the status indicator may shine green ifthe catheter 1100, 1200 or insertion aid 1106, 1206 has been used lessthan 75 times each; yellow if the catheter 1100, 1200 or insertion aid1106, 1206 has been used between 75 and 95 times; and red if thecatheter 1100, 1200 or insertion aid 1106, 1206 has been used between 95and 100 times. Other colors and usage times may be utilized withoutdeparting from this invention. The sterilizer 1000 may include an LEDpixel matrix that visually indicates to the user how much time is leftin the sterilization cycle.

The sterilizer 1000 may include various software features. Thesterilizer 1000 may include an automated replenishment. For example,based on number of uses remaining in the plurality of catheters 1100,1200 and insertion aids 1106, 1206 used with the sterilizer 1000, thesystem can automatically initiate a catheter reorder with the user'smedical device distributor. In another embodiment, the sterilizer 1000may include catheterization analysis. For example, the software mayanalyze the frequency of catheterization based on detection of catheterremoval from the sterilizer [RFID reader scans the sterilizer interiorevery time the door 1006 is opened or closed] and frequency ofsterilization cycles. In another embodiment, the sterilizer 1000 mayinclude application pairing, where the sterilizer 1000 may pair with adigital application on a mobile device to provide more detailed statusupdates and diagnostics of the device 1000 to the user. The sterilizermay use data gathered from the application [UTI incidence, urologistcheck-ups, etc.] to augment its analysis of the user's catheterizationdata. In another embodiment, the sterilizer 1000 may include EHRintegration to provide urologists with seamless, real-time updates oncatheterization frequency and sterilizer analysis.

The sterilizer 1000 may also include portable, battery-poweredsterilizer 1000 that primarily utilizes UVC LEDs to sterilize usedcatheters 1100, 1200 between uses. This portable sterilizer 1000 wouldlikely have a carrying capacity of one catheter 1100, 1200 and insertionaid 1106, 1206 at a time.

According to another embodiment, a catheter scrubber may be utilized.The scrubber may be a 12-inch-long silicone brush that can scrub theinterior of a catheter 1100, 1200 without materially damaging thecatheter 1100, 1200 itself. The scrubber may be used to reducebiofilm/pathogenic residue on the inside surface of the catheter 1100,1200. The scrubber may be coated or coatable with an additionaldisinfecting agent [powder or liquid].

The sterilizer 1000 may include a digital application for use with amobile device. The digital application may be a companion applicationfor the sterilizer 1000 that features added functionality for the user.For example, the digital application may provide on-the-go validationand usage information, such that the application can scan each catheter1100, 1200 and insertion aid 1106, 1206 using the RFID/NFC technology inmost mobile phones to validate authenticity and tell individuals howmany uses they have left. In another embodiment, the digital applicationmay include replenishment reminders and confirmation, such that theapplication can insert reminders in their calendar to re-order cathetersfrom their distributor and update these reminders based on real-timeusage of catheters. The application can additionally notify users ofautomated replenishment orders and ask for their consent beforesubmitting the order for fulfillment. In another embodiment, the digitalapplication may include location-based data gathering, such that usingthe application with location services enabled allows the application toask individuals contextual questions. For example, if located near ahospital, the application may ask the user if they are experiencingUTI-like symptoms. Similar survey questions may be sent out periodicallyin the absence of location services to gather UTI-incidence data foranalysis of catheterization habits and UTI incidence. The digitalapplication may utilize anonymized data gathered across all users of thesystem and the application may suggest behavioral changes to limit UTIincidence.

In another embodiment, as illustrated in FIG. 15, a method 1500 forsterilizing one or more medical devices using electromagnetic radiationmay include the steps of: enclosing one or more medical devices in asterilizer 1510; scanning, by an RFID scanner within the sterilizer, theone or more medical devices placed within the sterilizer to validate theauthenticity of the one or more medical devices 1512; write, by the RFIDscanner, data to an RFID chip embedded in each of the one or moremedical devices 1514; sealing the sterilization chamber with a door thathinges open to allow individual access to the one or more medicaldevices 1516; starting a sterilization cycle with an internal controlcircuit for controlling the sterilization cycle with sterilizer software1518; and irradiating surfaces of the one or more medical devices withelectromagnetic radiation from at least one electromagnetic UV-Cradiation source 1520.

Moreover, the various features of the representative examples and thedependent claims may be combined in ways that are not specifically andexplicitly enumerated in order to provide additional useful embodimentsof the present teachings. It is also expressly noted that all valueranges or indications of groups of entities disclose every possibleintermediate value or intermediate entity for the purpose of originaldisclosure, as well as for the purpose of restricting the claimedsubject matter. It is also expressly noted that the dimensions and theshapes of the components shown in the figures are designed to help tounderstand how the present teachings are practiced, but not intended tolimit the dimensions and the shapes shown in the examples.

The scope of the present devices, systems and methods, etc., includesboth means plus function and step plus function concepts. However, theclaims are not to be interpreted as indicating a “means plus function”relationship unless the word “means” is specifically recited in a claim,and are to be interpreted as indicating a “means plus function”relationship where the word “means” is specifically recited in a claim.Similarly, the claims are not to be interpreted as indicating a “stepplus function” relationship unless the word “step” is specificallyrecited in a claim, and are to be interpreted as indicating a “step plusfunction” relationship where the word “step” is specifically recited ina claim.

It is understood that the embodiments described herein are for thepurpose of elucidation and should not be considered limiting the subjectmatter of the disclosure. Various modifications, uses, substitutions,combinations, improvements, methods of productions without departingfrom the scope or spirit of the present invention would be evident to aperson skilled in the art.

Several alternative embodiments and examples have been described andillustrated herein. A person of ordinary skill in the art wouldappreciate the features of the individual embodiments, and the possiblecombinations and variations of the components. A person of ordinaryskill in the art would further appreciate that any of the embodimentscould be provided in any combination with the other embodimentsdisclosed herein. Additionally, the terms “first,” “second,” “third,”and “fourth” as used herein are intended for illustrative purposes onlyand do not limit the embodiments in any way. Further, the term“plurality” as used herein indicates any number greater than one, eitherdisjunctively or conjunctively, as necessary, up to an infinite number.

It will be understood that the invention may be embodied in otherspecific forms without departing from the spirit or centralcharacteristics thereof. The present examples and embodiments,therefore, are to be considered in all respects as illustrative and notrestrictive, and the invention is not to be limited to the details givenherein. Accordingly, while the specific embodiments have beenillustrated and described, numerous modifications come to mind withoutsignificantly departing from the spirit of the invention and the scopeof protection is only limited by the scope of the accompanying Claims.

We claim:
 1. A sterilizer for sterilizing one or more medical devices, the sterilizer comprising: a housing including one or more walls defining a sterilization chamber for containing a sterilant and for enclosing the one or more medical devices, the housing having one or more openings for receiving the one or more medical devices and a door that opens to allow individual access to the one or more medical devices, the door providing a seal between the sterilization chamber and an external environment when closed; at least one sterilant source comprising a plurality of sterilant generators arranged in an at least one array, wherein the plurality of sterilant generators are positioned to generate the sterilant within the sterilization chamber; one or more trays, wherein each tray is substantially transmissive to the sterilant generated in the sterilizer and can independently be inserted into and removed out of the sterilizer for ease of loading by a user; and an internal control circuit for controlling a sterilization cycle with sterilizer software, the internal control circuit includes an scanner to scan the one or more medical devices and a plurality of sensors that validate the sterilizer is completely closed during the sterilization cycle, prevent sterilization of non-system components by recognizing a placement of the non-system components within the sterilizer and an absence of a valid scan on the non-system components and preventing activation of the sterilization cycle, and prevent emission of the sterilant into the external environment, and wherein the plurality of sensors located within the housing and the sterilization cycle continues until the plurality of sensors has received a sterilization dose greater than or equal to a minimum sterilization dose set within the internal control circuit, wherein each tray is registered to accept a placement of the one or more medical devices in a specific orientation to enable each device to be scanned by one or more scanners located in the sterilizer to scan each medical device placed into the sterilizer.
 2. The sterilizer of claim 1, wherein the internal control circuit and the scanner validates an authenticity and a remaining longevity of each one of the one or more medical devices placed within the sterilizer in order to begin the sterilization cycle and writes data to a data-storage tag in each of the one or more medical devices following a successful completion of the sterilization cycle.
 3. The sterilizer of claim 2, further comprising a user interface that indicates to the user the remaining longevity of each medical device placed in the sterilizer, based on a successful reading and authentication of the data-storage tag of each medical device when it is placed in the sterilizer.
 4. The sterilizer of claim 1, wherein the plurality of sensors includes one or more of the following: a Hall Effect sensor, a temperature sensor, a humidity sensor and a pressure sensor, wherein the plurality of sensors collect a set of data that is continuously transferred into the internal control circuit to increase a duration of the sterilization cycle so long as a set of pre-defined parameters are not met.
 5. The sterilizer of claim 1, wherein the sterilant source is a plurality of thermal elements.
 6. The sterilizer of claim 5, wherein the plurality of thermal elements causes a water supply to vibrate and heat up to generate the sterilant source comprising steam.
 7. The sterilizer of claim 1, wherein the sterilant source is one or more of the following: a plurality of UV-C LEDs, a plurality of infrared emitters, or a plurality of microwave emitters.
 8. The sterilizer of claim 1, wherein the sterilant comprises ultraviolet wavelengths of radiation.
 9. The sterilizer of claim 1, wherein the sterilant comprises infrared wavelengths of radiation that generates heat.
 10. The sterilizer of claim 1, wherein the sterilant comprises microwave wavelengths of radiation.
 11. The sterilizer of claim 1, wherein the sterilization chamber maintains a pressurized environment.
 12. The sterilizer of claim 1, wherein the at least one of the sterilant sources are contained within the one or more walls of the sterilization chamber and distributed such that each tray is located proximal to at least one sterilant source when the sterilizer is closed.
 13. The sterilizer of claim 1, wherein the at least one of the sterilant sources are distributed throughout an inner surface of the sterilization chamber.
 14. The sterilizer of claim 1, wherein the sterilizer software pairs with a digital application for a mobile device to provide a user with detailed sterilizer status updates and diagnostics of the one or more medical devices to the user, as well as the ability to initiate sterilization cycles, stop sterilization cycles, receive push notifications, examine aggregated sterilizer usage data, and receive sterilizer troubleshooting instructions.
 15. The sterilizer of claim 14, wherein the digital application indicates the remaining longevity of the medical device after the medical device has been scanned.
 16. The sterilizer of claim 14, wherein collected data is stored on-board the sterilizer or transmitted to the digital application in a HIPAA-compliant fashion.
 17. The sterilizer of claim 1, wherein the trays are mounted such that when the sterilizer is opened, the trays are pushed towards the sterilizer opening, enabling easy access to the trays by the user.
 18. A method for sterilizing one or more medical devices using a sterilant comprising: removing and inserting one or more trays from a sterilizer that each tray corresponds to one or more medical devices, wherein each tray is substantially transmissive to the sterilant generated in the sterilizer and is independently inserted into and removed out of a sterilizer for ease of loading by a user; cleaning one or more medical devices with a silicone brush capable of dispersing chemical sterilizing agents while abrading pathogenic residue from the surfaces of the medical devices; enclosing one or more medical devices via the trays in the sterilizer, the sterilizer including a housing with one or more walls defining a sterilization chamber for containing the sterilant; scanning, by a scanner within the sterilizer, the one or more medical devices placed within the sterilizer to validate the one or more medical devices; writing, by the scanner, data to a data storage device in each of the one or more medical devices; sealing the sterilization chamber with a door opens to allow individual access to the one or more medical devices, the door providing a seal between the sterilization chamber and an external environment when closed; starting a sterilization cycle with an internal control circuit for controlling the sterilization cycle with sterilizer software, the internal control circuit further including a plurality of sensors that validate the sterilizer is completely closed during the sterilization cycle, prevent sterilization of non-system components by recognizing a placement of non-system components within the sterilizer and an absence of a valid scan on the non-system components and preventing activation of the sterilization cycle, and prevent emission of the sterilant into the external environment, and wherein the plurality of sensors located within the housing and the sterilization cycle continues until the plurality of sensors has received a sterilization dose greater than or equal to a minimum sterilization dose set within the internal control circuit; and exposing surfaces of the one or more medical devices with the sterilant from at least one sterilant source arranged in an at least one array and embedded within the one or more walls of the sterilization chamber, wherein the sterilant source is positioned to provide the sterilant within the sterilization chamber thereby destroying biological contaminants on the surfaces of the one or more medical devices.
 19. The method of claim 18, wherein the plurality of sensors include one or more of the following: a Hall Effect sensor, a temperature sensor, a humidity sensor, and a pressure sensor, wherein the plurality of sensors collect a set of data that is continuously transferred into the internal control circuit to increase a duration of the sterilization cycle so long as a set of pre-defined parameters are not met.
 20. The method of claim 18, wherein the one or more medical devices includes up to six catheters and catheter insertion aids.
 21. A sterilization system comprising: one or more urinary intermittent catheters made from sterilization-resilient and flexible material, the one or more catheters including a curved funnel and a first data-storage tag that contains authentication information and usage information; one or more catheter insertion aids that mate with the one or more catheters and provide support and lubrication to the one or more catheters, the one or more insertion aids including a flexible insertion tip that is similar to a French size of the catheter, the one or more insertion aids further including a second data-storage tag that contains authentication information and usage information; and a sterilizer including: a housing including one or more walls defining a sterilization chamber for containing a sterilant and for enclosing the one or more catheters and the one or more insertion aids, the housing having one or more openings for receiving the one or more catheters and the one or more insertion aids and a door that opens to allow individual access to the one or more catheters and the one or more insertion aids, the door providing a seal between the sterilization chamber and an external environment when closed; one or more trays that each correspond to the one or more catheters and the one or more insertion aids, wherein each tray is substantially transmissive to the sterilant generated in the sterilizer and can independently be inserted into and removed out of the sterilizer for ease of loading by a user; at least one sterilant source comprising a plurality of sterilant generators arranged in an at least one array, wherein the generators are positioned to generate the sterilant within the sterilization chamber; and an internal control circuit for controlling a sterilization cycle with sterilizer software, the internal control circuit includes a scanner to scan the first data-storage tag embedded in each one of the one or more catheters and the second data-storage tag embedded in each one of the one or more insertion aids that validates an authenticity and a remaining longevity of each one of the one or more catheters and the one or more insertion aids placed within the sterilizer in order to begin the sterilization cycle and writes data to the first and second data-storage tags in each of the one or more catheters and the one or more insertion aids, the internal control circuit further including a plurality of sensors that validate the sterilizer is completely closed during the sterilization cycle, prevent sterilization of non-system components by recognizing a placement of non-system components within the sterilizer and an absence of a valid scan on the non-system components and preventing activation of the sterilization cycle, and prevent emission of the sterilant into the external environment, and wherein the plurality of sensors located within the housing and the sterilization cycle continues until the plurality of sensors has received a sterilization dose greater than or equal to a minimum sterilization dose set within the internal control circuit, wherein each tray is registered to accept a placement of the one or more urinary intermittent catheters and the one or more catheter insertion aids in a specific orientation to enable each device to be scanned by one or more scanners located in the sterilizer to scan each medical device placed into the sterilizer.
 22. The sterilizer system of claim 21, wherein the plurality of sensors include one or more of the following: a Hall Effect sensor, a temperature sensor, a humidity sensor, and a pressure sensor, wherein the plurality of sensors collect a set of data that is continuously transferred into the internal control circuit to increase a duration of the sterilization cycle so long as a set of pre-defined parameters are not met.
 23. The sterilization system of claim 21, wherein the sterilizer software pairs with a digital application for a mobile device to provide a user with detailed sterilizer status updates and diagnostics of the one or more medical devices to the user.
 24. The sterilization system of claim 23, wherein the sterilizer software includes an automatic replenishment mode to automatically initiate a medical device reorder with a user's medical device distributor for the one or more medical devices based on a number of scan-validated uses remaining in the one or more medical devices used with the sterilizer, and further wherein the automatic replenishment mode utilizes a pre-populated shopping cart in the digital application that requires user consent before the digital application transmits the shopping cart to a user's medical device distributor. 